Policy and Medicine

FDA Official Cleared of Conflict Allegations in Heparin Contamination Case

Last week Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA was cleared of a conflict of interest allegation.    The charge came from her engagement of a firm developing a low molecular weight heparin generic, to find the source of the 2008 heparin contamination.

In 2008, Dr. Woodcock, and scientists at Momenta Pharmaceuticals were among a team of researchers that identified a contaminant in Chinese-imported heparin marketed by Deerfield, Illinois-base Baxter International that was sickening and, in some cases, killing patients. According to The Baltimore Sun, the findings were reported in a pair of science journals in April 2008.

In competition with Momenta to develop the drug was Amphastar Pharmaceuticals, Inc., located in Rancho Cucamonga. Both the version of heparin under development by Amphastar and Momenta is chemically similar but distinct from the form of the Baxter drug, according to the Sun.

Problems arose in April 2009, when Amphastar raised conflict allegations against Dr. Woodcock’s work with the drug. “Amphastar alleged that Woodcock's research work with Momenta essentially forged a bond with the company and created the appearance of a conflict.” Amphastar also alleged in its complaint that “earlier contacts in 2007 between Woodcock and Momenta-connected scientists discussing issues that would later figure in requirements imposed on both companies' applications.”

Eventually, Dr. Woodcock “voluntarily removed herself from considering the application, as well as a competing one filed by Amphastar Pharmaceuticals.”

Last week however, FDA legal counsel Ralph Tyler announced that “the research collaboration between Janet Woodcock, and scientists at Momenta Pharmaceuticals during the 2008 heparin crisis did not constitute a conflict, even though the drugmaker had an application pending before the agency.”

Mr. Tyler asserted that there was “no conflict” and that “as an act of good grace Woodcock stepped aside from any involvement in both applications last August.” In addition to this announcement, Mr. Tyler also acknowledged that the investigation by the Department of Health and Human Services Inspection General was dropped.

An attorney for Amphastar, Jason Shandell, was not happy with the announcement. He questioned the timing of Woodcock’s withdrawal from the study, and how the FDA contacted reporters before notifying his company. He asserted that that agency had handled the matter contrary to the “face of transparency” advocated by the Obama Administration.

In defending the stance of the FDA, principal deputy commissioner Josha Sharfstein told the Sun that “the agency needed to be able preserve its ability to respond to public health emergencies and also assure safety of new products.” Mr. Sharfstein further added that just because officials are involved in “both activities, does not mean they are automatically conflicted.  

Ultimately, this case demonstrates an extremely important consideration: there is a difference between conflict and confluence.  

In this case, it is clearly in the nation’s best interest that FDA officials have access to the most knowledgeable scientists to solve public health issues, and that means access to company scientists and technologies.

Obama Budget for Fiscal Year 2011: Health Care Provisions

This week, the Obama administration released a proposed budget for Fiscal Year 2011, with and overall total spending of $3.834 trillion. The budget also allocates $50.6 billion in advance appropriations for the Veteran’s Administration (VA) medical care program so that care for the Nation’s veterans is not hindered by budget delays.

Below is a summary of the proposed budget for the Department of Health and Human Services (HHS) and some of its major agencies. In addition, Health and Human Services (HHS) Secretary, Kathleen Sebelius, gave a speech announcing some of the departments goals for the upcoming fiscal year in response to the President’s proposed budget.

The Budget includes $561 million in discretionary resources, an increase of $250 million, to strengthen Medicare and Medicaid program integrity activities, with a particular emphasis on fighting health care fraud in the field, increasing Medicaid audits, and strengthening program oversight while reducing costs. 

Such an investment against fraud and abuse claims to help save $9.9 billion over ten years. According to HHS, the additional funding will better equip the Federal government to minimize inappropriate payments, pinpoint potential weaknesses in program integrity oversight, target emerging fraud schemes by provider and type of service, and establish safeguards to correct programmatic vulnerabilities.

Additionally, the HHS budget will install a set of new program integrity proposals that will give HHS the necessary tools to fight fraud by enhancing provider enrollment scrutiny, increasing claims oversight, improving Medicare’s data analysis capabilities, and reducing over-utilization of Medicaid prescription drugs.  These proposals will claim to save approximately $14.7 billion over 10 years.

Other healthcare related budget expenditures include:

• $3.6 billion, an increase of $186 million, to CMS to meet current administrative workload demands from recent legislative requirements and continuous beneficiary growth. The money also helps revamp information technology (IT) systems and optimize staffing levels so that CMS can meet the future challenges of the Medicare and Medicaid programs and can be an active purchaser of high quality and efficient care.
• $110 million of CMS’ increase is for a new, comprehensive Health Care Data Improvement Initiative to transform CMS’s data environment from one focused primarily on claims processing to one also focused on state-of-the art data analysis and information sharing. 
• $1 billion in funding is budgeted to strengthen and support the country’s health care workforce by increasing the capacity of nursing schools, helping more low-income and minority students become doctors, and ensuring that America’s seniors can get care when they need it. This funding will expand loan repayment programs for physicians, nurses, and dentists who agree to practice in medically underserved areas. 
• An increase of $290 million for further expansions of health center services, including the creation of 25 new access points in communities without access to a health center, and will facilitate the integration of behavioral health into the existing health centers’ primary care system. 
• $78 million, an increase of $17 million, for the Office of the National Coordinator for Health Information Technology (ONC) to advance the President’s health IT initiative by accelerating health IT adoption and electronic health records (EHRs) utilization as essential tools to modernizing the health care system. 
• An additional $261 million, including program support costs, in the Agency for Healthcare Research and Quality (AHRQ) to support new research projects including comparative effectiveness research. 
• $20 million for a CDC initiative to reduce the rates of morbidity and disability due to chronic disease in up to ten of the largest U.S. cities.
• $162 million for Health Statistics, an increase of $23 million, to improve CDC’s ability to collect data on the health of the Nation for use by policy-makers and Federal, State, and local leaders.  This increase will ensure data availability on key national health indicators by supporting electronic birth and death records in States and enhancing national surveys.
• $222 million, an increase of $16 million, for Autism Spectrum Disorders (ASD).
• The Food and Drug Administration (FDA) will receive $3,237,218,000. Of this $3 billion, $1.4 billion, is for medical product safety.  This increase will enable FDA to invest in tools that will enhance the safety of increasingly complex drugs, medical devices, and biological products. Also, $61,860,000 of funds for HHS are derived from medical device user fees.
• $102.5 million in increased funding for a new Caregiver Initiative at Administration of Aging (AoA). 
• $32.2 billion for NIH, an increase of $1 billion, to support innovative projects from basic to clinical research. In FY 2011, NIH estimates it will support a total of 37,001 research project grants, including 9,052 new and competing awards. With regards to clinical research, HHS announced that “new partnerships between academia and industry are working to revitalize the drug development pipeline.” 
• $25 million for advancing regulatory science at FDA, $15 million of which is for nanotechnology related research. The additional resources will also enable FDA to update review standards and provide regulatory pathways for new technologies, such as biosimilars.

Ultimately, while significant amounts of money are budgeted for HHS and its related agencies to improve health care, the focus on clinical research and innovation for breakthroughs in treatment, drugs, and devices is inadequate.

For instance, on average, it costs approximately $1 billion for one drug to reach the market, and only $32.2 billion for NIH—an increase of $1 billion from last year—is being provided from the budget. Without the support of industry and other organizations to work in collaboration with academic medical centers and the government, advances will be limited. Certainly, it would be in the best interest of patients, doctors and Congress to begin discussing the shortfalls of such a budget for the kind of research and funding that is needed to help care for an increasingly sick and older population, especially if any sort of health care reform is passed. 

Washington Legal Foundation Files Brief on Behalf of Patient Organizations in Allergan Case

The Washington Legal Foundation (WLF) this week urged the U.S. District Court for the District of Columbia to uphold First Amendment rights by limiting the authority of the Food and Drug Administration (FDA) to bar drug manufacturers from speaking truthfully about off-label uses of their products. In a brief filed in support of a motion by

Allergan, Inc. for a preliminary injunction against FDA enforcement action, WLF argued that FDA has not provided sufficient justification for interfering with such speech when directed to medical professionals.

 

WLF filed its brief on behalf of several organizations representing patients that have a significant interest in encouraging open communications between their doctors and Allergan – the National Spasmodic Torticollis Association and the National Spasmodic Dysphonia Association. WLF also filed its brief on behalf of itself and the Allied Educational Foundation. WLF filed its brief with the pro bono assistance of Coleen Klasmeier, Eric Shumsky, Paul Kalb, and Brad Berenson, attorneys with the Washington, D.C. office of Sidley Austin LLP.

 

“Off-label” uses of a drug or medical device are uses of an FDA-approved product that have not received explicit FDA approval. Although federal law prohibits the manufacturer from specifying on the label any uses of the product other than the precise uses approved by FDA, doctors are free to prescribe FDA-approved products for uses other than those specified on the product label. Indeed, the medical community’s knowledge regarding the safety and efficacy of FDA-approved products inevitably outpaces FDA-approved labeling, with the result that a large percentage of state-of-theart medical treatments involves off-label uses.

 

Allergan, Inc. is the manufacturer of Botox, a drug approved by FDA to treat several conditions, including cervical dystonia. Dystonias are involuntary muscle contractions, and Botox is injected into the affected muscles to relax them. FDA has not approved Botox for treatment of other dystonias, including spasmotic dysphonia – a neurological voice disorder that causes the vocal chord to spasm and thereby prevents speech by those with the condition. Off-label use of Botox is considered the standard of care for tr eating spasmodic dysphonia. Because spasmodic dysphonia is often diagnosed by a neurologist but is treated by an otolaryngologist, it tends to fall between specialties, and few doctors possess both detailed knowledge of the disease and the expertise regarding how to make injections into the larynx. Allergan employees are among the few individuals with that combined expertise, and thus treating physicians are dependent on Allergan for vital treatment information – such as proper dosaging. But because of FDA speech limitations, Allergan risks criminal prosecutions if it attempts to provide such information to doctors.

 

In its brief urging the court to enjoin FDA efforts to prohibit truthful speech by

Allergan employees, WLF argued that the First Amendment fully protects such speech.

WLF further argued that even if Allergan’s speech could be deemed commercial in nature (and thus entitled to a somewhat reduced level of constitutional protection), FDA’s speech restrictions still violate First Amendment norms. WLF argued that FDA has failed to demonstrate either that its speech restrictions directly advance any substantial government interests, or that the restrictions are narrowly tailored. WLF stated that FDA’s restrictions are a paternalistic effort to control the content of scientific discussion and a disservice to public health.

 

WLF noted that FDA is free to restrict Allergan’s speech to the extent that it believes that the speech is misleading, and to require Allergan to attach appropriate disclaimers to its speech – such as a warning that FDA has not approved the off-label uses that Allergan is discussing.

 

This is an important case in that if settled for the Allergan, many of the cases pending in state courts and by the IOG will be dismissed because they largely cover a very literal interpretation of restricting communications of “off label” information.

FDA Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media – Webcast and Testimony

During the next two days we will be hearing from experts around the country at the FDA Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media, a number of good ideas will be presented.

There are a number of websites with links to testimony covering the event and the live webcast. 

One twitter site has live tweets (thanks to the reader who set me straight on this)

http://www.fdasm.com/

For a live video and audio feed of the hearing:

http://www.capitolconnection.net/capcon/fda/111209/FDAlive.htm#

FDA Agenda, Speakers, and Other Documents.

We have highlighted several testimonies.  As more testimonies come in we will provide links to them.

Arnold Friede

Speaking from over 35 years of food and drug law experience, Arnold I. Friede, a former Associate Chief Counsel in the FDA’s Office of Chief Counsel, offered a refreshing look at a regulatory pathway to advance public health by enabling robust marketing by regulated companies, and at the same time coordinating effective enforcement against health fraud on the Internet.

In his written testimony before the panel, Mr. Friede noted three primary interpretive impediments to FDA policy on the use of Social Media and the Internet. First, where and how risk information must be disclosed in advertising and promotion. Second, whether and when statements should be attributed to a medical product “sponsor” for purposes of the prohibition on “off-label” promotion. Finally, mandatory reporting requirements whenever a sponsor becomes “aware of” information suggesting that an adverse event may have been caused (or “contributed to”) by one of the sponsor’s products.

During his first day of testimony Mr. Friede offered a framework of how to approach these hurdles. He noted that FDA’s position to requrie instantaneous and contemporaneous disclosure of all risk information whenever a product name and any mention of any product attribute appear together in a sponsored medium, is problematic.  Mr. Friede explained that such a requirement is not “always possible or even desireable.”

Instead, he offered a an alternative: FDA should focus on context in determining the adequacy of risk disclosur. Such a notion Mr. Friede reminded the panel, is consistent with the approach FDA has taken to “bookending” of help seeking and reminder advertisements, where FDA has said that it will look to overall context, including perceptual similarity, in deciding if the two in proximity to each other should be considered a single “advertisement” subject to risk disclosure requirements. 

The focus on context would also be consistent with the statutory definition of “labeling”, which looks at overall “context” in determining when an item “accompanies” a product so that it is deemed, by law, to be “labeling”.

Another argument for the use of context are existing regulations that apply to direct-to-consumer (DTC) television advertising, where FDA acknowledges that contemporaneously available complete risk information, even if not physically or technologically connected in any way to the advertising in question, can nevertheless satisfy statutory risk disclosure requirements. This so called “adquate provision” should be used for Social Media, Mr. Friede asserts.  

Moving onto the topic of off-label promotion, Mr Friede acknowledged that not all “off-label” statements by anyone on an Internet web site or Social Media site operated or sponsored by a pharmaceutical or medical device manufacturer are inappropriate. In fact, to suggest so would seriously hurt the “information marketplace” where many consumers and patients have learned to depend on social media.

The liability of having such statements on sponsored sites could hurt companies, “such as Sidewiki, where information can be posted to, and effectively become part of,  a web site without any involvement whatsoever by the manufacturer and can thereafter be viewed by anyone with the appropriate Internet tools.”

When a manufacturer has done nothing more than provide a a facility whereby someone posts an unsolicited off-label comment, there should be no liability. Sponsored sites should however, have the ability to direct or control the content of the posting, or delete it or disclaim it. In fact, the “FDA, has acknowledged in a variety of circumstances that a manufacturer is not automatically liable for third party behavior that it does not dictate or have the ability to control.” 

Likewise in the context of its Guidance on Continuing Medical Education (CME), FDA has implicitly acknowledged that agency law principles of “direction and control” are relevant in determining if “off-label” CME will be imputed to a manufacturer who provides funding for a CME program. With regards to social media, Mr. Friede believes FDA should also direct and control “the content of a communication, for when a company that maintains or sponsors a Social Media or other Internet web site is legally responsible for "off-label" communications posted there.” 

Consequently, Mr. Frieder also recommends the FDA adopt the Federal Trade Commission (FTC) policy where “by third party bloggers are imputed to a product “sponsor” only if there are indicia of direction and control by the sponsor over the content of the communication.  Otherwise, the product sponsor will not be liable for the endorsement.” 

On his second day of testimony, Mr. Frieder spoke about the Adverse Event Reporting System (AERS or AE). He explained how “the concern about AE reporting stems from FDA rules that mandate reporting whenever a sponsor becomes “aware of” information of sufficient specificity showing that the sponsor’s product may have caused, or contributed to, an AE.”

In addressing this concern, he asserted that there is no need to worry about such requirements for two reasons. First, because “some of this information is likely duplicative of what has already been reported.” Second, “because some is undoubtedly cumulative in the sense that the incidence and severity of the AE is already fully and completely addressed in the product’s labeling and the additional information does not add meaningfully to what we know about the product’s risks and how to manage them.” 

He also appeased such a concern by noting that “companies probably spend 99% of the time in safety monitoring in finding and reporting the very last AE.” In addition, the FDA also spent $2.7 million on study these reports. As a result, Mr. Frieder simply asked that the agency to wait until the system has been “empirically validated as a meaningful basis for regulatory decision making,” before worrying about how social media impacts such reporting.  

Coalition for Healthcare Communications

Also presenting at the meeting was John Kamp, Executive Director of the Coalition for Healthcare Communication. Mr. Kamp’s  remarks were also on behalf of The American Association of Advertising Agencies (AAAA).

Mr. Kamp propsed that FDA’s policy should foster increased, more reliable health information on the Internet. Such an increase is necessary because professionals consumers, companies and social media sites are relying on industry partnerships to support provision of trusted health information.

These health care providers, through industry support, are using social media to have conversations online to improve patient care, and provide a venue for persons to have group discussions regarding treatments and emotional needs.

Since industry information and financial support are so vital to different forms of social media, Mr. Kamp called for transparent industry involvement. Sites should include places for consumers and professionals to find FDA regulated information (FRI), and use new intra-industry and inter-agency efforts to fight widespread Web healthcare inaccuracy and fraud.

Organizations like the Coalition and AAAA recognize the power and public health promise of social websites, and would use these new efforts to show consumers and professionals that industry promotion on these sites is overseen by FDA.

Accordingly, Mr. Kamp noted that when dealing with potential problems, not all of the blame should be placed on industry, especially when many of the social media sites are in control by the individual user. New efforts must control the information being shared. There should not be a feeling of big brother where there is already control by FDA regulations for company sites and advertising.

Concluding his presentation, Mr. Kamp asserted that the best way of addressing these issues is to enable and strengthen the incredible information and conversations on the Internet these social media allow through industry support and collaboration that has clear guidance for users. These standards should be applied on a national level, and regulatory policies should be supported by linking techniques to make  FDA regulated details more accessible to  professionals, patients and care givers.

GAO to FDA: Action Needed to Improve Timeliness on Clinical Investigator Oversight

The Government Accounting Office ("GAO") published a new report on the oversight of clinical investigators titled, “Oversight of Clinical Investigators: Action Needed to Improve Timeliness and Enhance Scope of FDA’s Debarment and Disqualification Processes for Medical Product Investigators.” The report offers a critical look at the process FDA uses in such oversight by citing numerous instances where FDA did not take timely action to respond to situations where debarment or disqualification of a clinical investigator was at issue. 

Under Federal Food, Drug, and Cosmetic Act ("FDC Act"), debarment is mandatory if an individual has been convicted of a felony under federal law for conduct relating to the regulation of a drug.  A mandatory debarment is permanent.  In a permissive debarment, FDA may debar an individual if he or she has been convicted of a misdemeanor under federal law or a felony under state law if the conduct relates to the development or approval process of a drug, or if the individual has been convicted of certain felonies not related to drug development.  Permissive debarment is for a period of time up to five years. 

Pursuant to FDA regulations, FDA may also disqualify investigators (i.e., determine that a clinical investigator is not entitled to receive investigational drugs or devices) who repeatedly or deliberately fail to comply with FDA regulations or report false information to FDA or a trial sponsor.

Since the seriousness of these charges are profound, GAO’s report reviewed factors contributing to delays in FDA’s debarment and disqualification proceedings such as (1) the length of time FDA’s debarment proceedings have taken and the factors contributing to the length of time they have taken, (2) the length of time FDA’s disqualification proceedings have taken and the factors contributing to the length of time they have taken, and (3) statutory and regulatory limitations to debarment and disqualification.

The GAO reviewed 18 debarment proceedings and 52 disqualification proceedings between May 13, 1992—when FDA was first given the authority to take such actions—through September 9, 2008. The results of the report found that debarment proceedings ranged in length from 26 days to more than a decade. For debarment proceedings, 13 involved clinical investigators and 5 involved study coordinators. More than half of the debarment proceedings took over 4 years, and the median length for a proceeding was 4.4 years.  The median length for a disqualification proceeding was 2.5 years, with over a third of the proceedings taking more than 2 years. 

GAO also reported that permissive debarment proceedings generally took longer than mandatory proceedings. Of the 11 completed debarment proceedings, 5 were permissive debarment proceedings that took 4 or more years from conviction to debarment, with a median of 5.0 years. In contrast, six completed mandatory debarment proceedings took from just over 1 year to just over 6 years from conviction to debarment, with a median of 3.1 years.

Also for debarment proceedings, those involving individuals generally took longer to complete. Five of the 18 proceedings we reviewed involved individuals who responded to FDA’s proposal to debar letter by requesting a formal hearing to contest debarment. These proceedings took from 6 months to about 6 years, with a median of 2.2 years, from FDA’s issuance of a proposal to debar letter

As a result of such delays, the report acknowledged that the FDA is working to improve its debarment and disqualification procedures and will “endeavor to incorporate” the GAO’s recommendations. FDA also stated that the Agency would be drafting a guidance document to explain the disqualification process. 

Accordingly, the FDA identified several factors that contributed to the length of time taken to complete the debarment proceedings. These factors included:

 

-   A lack of systematic procedures to help ensure timely communication of information relevant to debarment (such as conviction information);

 

-   A lack of policies, expectations and procedures for FDA staff that established time frames for debarment actions;

 

-   Limited resources due to competing priorities;

 

-   A lack of communication between staff responsible for debarment and other FDA staff having information on convictions

 

Although some of these factors are being dealt with presently by the FDA, the report addresses that the results are still unknown, and problematic. For example, implementing the new time frames that FDA has established for debarment and disqualification could be challenging because some of these time frames are substantially shorter than the times FDA actually took in the proceedings we reviewed. Additionally, given the agency’s competing priorities, it remains to be seen whether FDA will dedicate sufficient resources to debarment or disqualification proceedings to meet the time frames.

GAO summarized its report by offering recommendations to strengthen FDA’s oversight of clinical investigators (GAO Report page 43):

· Pursue debarment authority for medical devices that is consistent with the current debarment authority for drugs and biologics and prohibit any debarred individual from involvement with drugs, biologics, and medical devices.    

· Amend FDA regulations to ensure that those who have engaged in misconduct found sufficiently serious to warrant disqualification for one investigational medical product are not able to continue to serve as clinical investigators for any.    

· Monitor compliance with recently established time frames for debarment and disqualification proceedings and take appropriate action when those are not met.

The problems with FDA’s oversight into debarment and disqualification highlights the limited resources and time the agency has. By continuing such an inefficient process, the FDA is preventing companies and researchers from creating life saving devices and medicines that will save lives. While it is important to have oversight, these proceedings must be made timelier to help more patients, and to keep businesses funding such breakthroughs in order to advance science and educate physicians.

FDA Issues Draft Guidance on Medical Device User Fee and Modernization Act

The Food and Drug Administration (FDA) gave notice to the public of a Proposed Guidance Development on the Web for the Medical Device User Fee and Modernization Act of 2010.

According to the Federal Register, the FDA agreed, in return for additional funding from industry, to meet a variety of quantitative and qualitative goals intended to help get safe and effective medical devices to market more quickly.

During negotiations over the reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA), the FDA made commitments to include annually posting a list of guidance documents that the Center for Devices and Radiological Health (CDRH) is considering for development and providing stakeholders an opportunity to provide comments and/or draft language for those topics, or suggestions for new or different guidance’s.

The list includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CDRH has already issued level 1 drafts that may be finalized following review of public comments. The CDRH list will be focused exclusively on device-related guidances. The FDA requests that comments from stakeholders indicate the relative priority of different guidance topics to interested stakeholders.

The FDA has established a specific docket where comments about the fiscal year 2010 list, draft language for guidance documents on those topics, and suggestions for new or different guidances may be submitted on the FDA Web site.

Comments may be submitted at any time to http:// www.regulations.gov. Identify comments with Docket No. FDA–2007–N–0270.

FDA Announces Strategic Plan for Risk Communication

The FDA today announced a Strategic Plan for Risk Communication that establishes a framework for communicating meaningful health information with the public about FDA-regulated products. Part of the plan also includes providing information about FDA-
regulated products to health care professionals, patients and consumers.

Margaret A. Hamburg, M.D., Commissioner of the FDA asserted that this plan will “communicate frequently and clearly the risks and benefits of certain products, and inform patients and consumers about ways to minimize risk as they become increasingly involved in managing their health and well-being.”
 

According to their press release, the FDA plan has three key areas–FDA’s science base, its operational capacity and its policy and processes. The plan also identifies over 70 specific actions for the FDA to take over the next five years, including 14 that the
agency commits to accomplishing over the next year. They include:

• Designing a series of surveys to assess the public’s understanding of, and satisfaction with, FDA communications about medical products;

 

• Producing a research agenda for public dissemination;

 

• Creating and maintaining a useful, easily accessible internal
  database of FDA and other relevant risk communication research;

 

• Developing an expert model to characterize tobacco-use related
  consumer decision-making and better understand the likely impact of
  FDA oversight of tobacco products;

 

• Developing a “library” of multi-media communications on safe
  food practices for general education purposes and for use with crisis
  communications concerning food contamination episodes;

 

• Posting pictures of FDA- regulated products affected by Class I
  or high-priority Class II recalls as part of recall notices/information; and

 

• Developing detailed action plans at the agency and center
  levels for implementing and achieving the proposed action steps,
  including timelines, responsibilities and resource needs

 

    The announcement of this plan seems strategically in place with a previously announced hearing on the Internet and Web 2.0 regarding how information about drugs and products are being conveyed to the public. Such a strategic plan is important for industry, physicians and patients because it will give health care providers more critical information about the products they use, it will help industry convey the risks associated with their products, and it will allow patients to make more educated decisions.

FDA Hires IOM to Review Medical Device Approval System

The Food and Drug Administration (FDA) recently issued a press release announcing the commissioning of the Institute of Medicine (IOM) to study the premarket clearance process for medical devices in the U.S.

According to the release, the IOM study will examine the premarket notification program, also called the 510(k) process, for medical devices, and the FDA’s Center for Devices and Radiological Health (CDRH) will convene its own internal working group to evaluate and improve the consistency of FDA decision making in the 510(k) process.

The goals of these evaluations according to Jeffrey Shuren, M.D., acting director of CDRH, is to help “determine how the 510(k) process can be improved to better support FDA’s mission to protect and promote the public health.”

The 510(k) process was established under the Medical Device Amendments of 1976 with two goals:

• Make safe and effective devices available to consumers
• Promote innovation in the medical device industry.

The release calls for review of the 510(k) process because “technology and the medical device industry have changed dramatically.” The IOM commission will specifically try to answer two principal questions:

• Does the current 510(k) process optimally protect patients and promote innovation in support of public health?
• If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process?

The $1.3 million IOM review is slated for completion in 2011. Part of the review will include two public workshops during the next nine months, as well a final report that will be published in March 2011. Dr. Shuren also noted that in addition to this review he has outlined six priorities for CDRH including:

• Creating an internal task force on the use of science in regulatory decision-making
• Developing an effective compliance strategy
• Optimally integrating premarket and postmarket information
• Increasing transparency in decision-making
• Establishing clear procedures to resolve differences of opinion.

While it is certainly important for the FDA and CDRH to monitor such changes, it is equally important not to hinder such breakthroughs—often led by collaboration with industry and academia—through burdensome evaluations that scare away scientists and researchers. The criteria IOM should focus on is ensuring that the technological breakthroughs from the medical device and drug industries are kept intact, so that we can keep treating patients and saving lives.   Simply setting up further delays in approvals does not constitute a solution.

For more information about the FDA premarket approval of devices read the GAO report on FDA system for device approval.

FDA Hearing on Internet and Web 2.0

 

At the beginning of the year the Food and Drug Administration (FDA) sent warning letters to 10 companies concerning advertising on the internet.   Recently the agency announced that they will be hosting a series of hearings on the internet and the web 2.0.  The eventual goal is to come up with a much needed guidance on drug and device advertising on the internet and social media.

 

FDA's Center for Drug Evaluation and Research (CDER), in collaboration with FDA's Center for Biologics Evaluation and Research (CBER), Center for Veterinary Medicine (CVM), and Center for Devices and Radiological Health (CDRH), recently gave notice of a public hearing it will be holding this November regarding the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools.

 

The hearing will discuss issues related to the promotion of FDA-regulated medical products (including prescription drugs for humans and animals, prescription biologics, and medical devices) using the Internet and social media tools.

 

Those members of the public interested in participating can find a list of questions and topics that will be discussed at the hearing from the link listed above.

 

Information

 

Interested persons may submit written comments (two copies required) to the Division of Dockets Management to:

 

Docket No. FDA-2009-N-0441

Division of Dockets Management (HFA-305), Food and Drug Administration 5630 Fishers Lane, rm. 1061, Rockville, MD 20852

 

Electronic comments should be submitted by going to http://www.regulations.gov and using electronic registration and electronic comments. Electronic comments should be identified with Docket No. FDA-2009-N-0441.

 

Written or electronic comments will be accepted until February 28, 2010.

 

Dates and Times: The public hearing will be held on November 12 and 13, 2009, from 8 a.m. to 5 p.m. each day.

 

Location: The public hearing will be held at the National Transportation Safety Board Conference Center, 429 L'Enfant Plaza, SW., Washington, DC 20594, 202-314-6305; Metro: L'Enfant Plaza station on the yellow, green, orange, and blue lines.

 

The meeting will take up several questions:

 

• What types and which online messages, posting and chatter are regulated companies responsible for? And what's not their problem?
• How do companies currently comply with existing regulations, how do those regulations apply to the internet, what changes need to be made, should they require fair balance in shorter communications?
• What responsibility does a company have to correct misinformation presented by a third party?    (for example Wikipedia, Yahoo and other websites that provide information free of control of industry)
• What links are appropriate?  When are links misleading.
• What reporting structure (to the FDA) should be in place for monitoring websites that include information on safety problems or side effects and the reliability of that information?

 

To register to attend and/or participate in the meeting, submit written or electronic registration as specified above by close of business on October 9, 2009. Registration is free and will be accepted on a first-come, first-served basis.

 

If you wish to make an oral presentation at the hearing, you must state your intention on your registration submission. To speak, submit your name, title, business affiliation, addresses, telephone and fax numbers, and e-mail address. Presenters should also identify by number each question they wish to address in their presentation and the approximate time requested. The FDA will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin. Once FDA notifies registered participants of their scheduled times, presenters should submit to FDA two copies of each presentation to be given

 

Transcripts of the hearing will be accessible after the hearing at http://www.regulations.gov.

 

For further information contact: Jean-Ah Kang, Division of Drug Marketing, Advertising, and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 3270, Silver Spring, MD, 20993-0002, 301-796-4269, FAX:

301-796-8444, e-mail: InternetPublicMeeting@fda.hhs.gov.

 

Conferences: Fourth Annual FDA Regulatory Symposium

The Fourth Annual Regulatory Symposium, Sept. 30-Oct. 2, 2009, in Washington, D.C., is only two days away and the entire event can is accessible both onsite and online.

 

The Symposium features a Who's Who of FDA's new leadership, including FDA Commissioner Margaret Hamburg, CDER Director Janet Woodcock, CDER Associate Director for Medical Policy Robert Temple, along with an array of other agency officials on the key regulatory issues facing drug and device companies. The agency's key decision makers will be joined by numerous industry thought leaders and outside experts to address the agency's regulatory and enforcement priorities. To review the entire agenda, visit: www.fdasymposium.com.

 

Topics covered in this FDA regulatory event include:

• FDA's Regulatory Agenda: Margaret Hamburg, FDA Commissioner
• Comparative Effectiveness: Robert Temple, CDER, FDA
• FDA's Safe Use Initiative: Janet Woodcock, CDER, FDA
• FDA Enforcement: Tom Abrams, CDER, FDA
• FDA's Device Approval and Safety Initiatives: Jonathan Sackner Bernstein, MD, CDRH, FDA
• The Agency's Approach to Social Media: Sanjay Koyani, FDA

In addition, five former FDA Chief Counsel to will address Off-Label Promotion, Enforcement, Preemption, and other key issues.

 

Also, industry thought leaders and outside experts will address the latest developments in Enforcement, Drug Safety, Risk Management and Social Media.

 

Conference Co-Chair Peter Pitts, the President of the Center for Medicine in the Public Interest, will steer the discussion on Day One and join other industry experts in assessing the industry's latest efforts related to managing conflicts of interest as part of a special panel discussion.

 

Date: Wednesday, Sept. 30 - Friday, Oct. 2, 2009

 

Location
Renaissance Washington DC Hotel
999 9th Street, N.W.
Washington DC 20001

 

Via the Web

The entire event can be accessed from the convenience of your office by visiting: www.fdasymposium.com/registration.html

 

For more details please visit www.fdasymposium.com