Life Science Compliance Update

December 07, 2017

Congress Taking New Approach to Opioid Epidemic


Recently, Representative Bob Latta introduced a bill into the United States House of Representatives. The bill, known as the Indexing Narcotics, Fentanyl and Opioids (INFO) Act, is intended to help create a public electronic database of information and strategies to combat the opioid crisis. The information in the database would be used to help federal, state, and local officials develop the most effective strategies to prevent addiction, treat those that are addicted, and keep prescription drugs from falling into the wrong hands. The INFO Act would also track federal funding being used to combat the epidemic.

The bill requires the Secretary of Health and Human Services (HHS) to appoint a Federal Coordinator to oversee the creation of the database, as well as coordinate related programs within HHS and serve as a liaison to state and local governments. The Federal Coordinator would work in consultation with the Department of Justice, Department of Veteran Affairs, the Office of National Drug Control Policy, and other relevant agencies.

The database would act as a central location for the public to find information on the following:

  • Federal funding allocations made available for research and treatment of opioid abuse;
  • Research relating to opioid abuse from all federal agencies, state and local governments, non-profits, law enforcement, medical experts, public health educators, and even research institutes.

The bill would also require HHS to evaluate other issues relating to pain management, addiction, prescription guidelines, treatments, trends and patterns, and effective solutions and programs used across the country.  HHS would be required to:

  • Examine causes and patterns in pain management and addiction;
  • Evaluate opioid abuse treatment programs, including medicated-assisted treatments, and determine their effectiveness;
  • Analyze opioid prescription guidelines, including types of opioids prescribed and trends, and recommend alternatives for pain treatment; and
  • Examine abuse rates among veterans versus the general population.

The Federal Coordinator would be responsible to submit a report to Congress one year after the date of enactment, and an additional report after five years, of results of any analysis, evaluation, or comparison conducted under their direction.

“Communities in Ohio and around the nation continue to suffer from the rise of opioid abuse and addiction,” said Latta. “While the magnitude of this crisis is evident in the number of opioid-related deaths, we’re still lacking basic information on the effectiveness of federal programs and other efforts. In order to develop the best plans to attack this problem, we need the best information. The INFO Act would improve data collection relating to addiction, prescription guidelines, treatment, pain management, patterns of abuse, and other areas in order to find help find solutions. When it comes to this crisis, failure is not an option.”

November 28, 2017

McCaskill Files Amendment to Eliminate Marketing Tax Deduction


Senator Claire McCaskill of Missouri recently filed an amendment to the tax bill to eliminate the deduction for pharmaceutical marketing. While the likelihood of a Democrat-proposed amendment to a Republican-controlled bill passing is slim, it is still important to understand the action McCaskill has taken.

Simply because the bill is controlled by the Republicans, the Republican majority in the Senate is thin, meaning bipartisan support is likely needed in order for any tax reform to be done. It is likely that McCaskill introduced this amendment to raise the profile of the issue and to see if there is any bipartisan support for the issue. John McCain has shown interest in “punishing” the pharmaceutical industry for high prescription prices.

Neither the House nor Senate versions of the Tax Cut and Jobs Act of 2017 contain the oft-proposed reduction of the deductibility of all marketing costs for client expenses. This general provision circulated for months in the drafting stage and has been the subject of significant lobbying by the Coalition for Healthcare Communication and others. However, the pharma-only provision has been circulating for a while – since the debates on the Affordable Care Act.

The McCaskill provision is a double threat in the Senate because it offers a bipartisan way to ding the unpopular pharma industry and would raise money to help pay for other popular deductions. When last “scored” by budget officials, the pharma-only change raised an estimated $10 billion over 10 years. To raise that amount, the change would need to apply to all pharmaceutical marketing, including detailing and provision of samples.

McCaskill has been known to be less-than-friendly to the pharmaceutical industry through her ideas, talking points, and legislative proposals. This proposed amendment is the most recent action she has taken to show her disdain for industry.

November 10, 2017

Insight into 21st Century Cures Implementation


According to a proposal of how 21st Century Cure funds will be used (subject to the congressional appropriations process), FDA released a document explaining the bulk would be dedicated to sections of the law on “Advancing New Drug Therapies” and “Patient Access to Therapies and Information.” Other funds will go to modernizing clinical trial designs, patient-focused drug development, medical device innovation and improving scientific expertise and outreach at FDA.

Cures Implementation

FDA proposes to allocate the authorized Innovation Account amounts to the activities that represent the best opportunity to achieve the goals of the Cures Act in conjunction with other funding sources subject to their availability. FDA’s proposed allocation does not spread the Innovation Account funds across all eligible sections. Some eligible provisions may assist FDA in carrying out its responsibilities but do not require any specific investment in new or expanded program activities. Others complement projects and commitments under current or anticipated reauthorized user fee programs and could be funded in part through some user fee resources subject to the availability of funds. Still others dovetail with on-going work supported by budget authority.

Charge to FDA Science Board

In the Cures Act, Congress requested “recommendations from the Science Board to the Food and Drug Administration, on the proposed allocation of funds … and on the contents of the proposed work plan.”

The Cures Act requires FDA to allocate Innovation Account funds for identified eligible activities. The resulting proposals were evaluated and prioritized according to the following criteria:

  • Provisions that present the greatest opportunity for FDA to foster innovation and integrate advances in biological sciences, engineering, information technology, and data science, to most directly improve the Agency’s product review tools and processes.
  • Provisions that address the greatest need for scientific modernization.
  • Provisions that have the most immediate impact on delivery of services to patients, the medical product industry, academia, and health professionals.
  • Provisions for which other funds may not be available.

Patient-Focused Drug Development

The Cures Act emphasizes the need for patient engagement and directs the Agency to include the patient’s voice in drug development and review. Section 3001 requires FDA to make public a brief statement regarding whether and how patient experience data and related information that was submitted, if any, was used in the review of a drug or biologic marketing application. Section 3002 requires FDA to issue one or more guidances for the purposes of drug development and regulatory decision making. Guidance should address such issues as acceptable methodological approaches for collecting, measuring, and analyzing patient experience data. Section 3004 directs FDA to issue reports at specified intervals assessing the use of patient experience data in regulatory decision making, especially focusing on the review of patient experience data and information on patient-focused drug development tools as part of approved applications.

In implementing these provisions FDA aims to facilitate a more systematic gathering and use of patients’ perspectives on their disease/condition and available therapies to treat their disease/condition. The work plan proposes to use Innovation Account funds to implement certain elements of these provisions.

Advancing New Drug Therapies

FDA must develop a new regulatory process under the Cures Act to qualify drug development tools (DDTs) in order to facilitate timely and consistent review of DDT qualification submissions and publicly disseminate broader information about DDTs under review and following a qualification determination. Once a DDT is qualified under this new process, any sponsor may use it for its qualified context of use to support an application for approval or licensure of a drug or to support the investigational use of a drug. Expert FDA staff and contractors will help develop evidentiary criteria needed to support qualification, develop regulatory informatics platforms, and integrate new review processes. This must occur quickly to ensure FDA can meet its obligations under this section within statutory timeframes, including developing and issuing guidance outlining procedures for the qualification process, holding public meetings, and posting public reports. Once fully implemented, this section has the potential to transform drug development and review.

Other Sections

FDA’s plan addresses several other important areas as mandated by the Cures legislation. First, under Modern Trial Design and Evidence Development, FDA notes Section 3021: Novel Clinical Trial Designs. This section directs FDA to assist sponsors in incorporating complex adaptive and other novel trial designs into proposed clinical protocols and applications for new drugs and biological products in order to facilitate more efficient product development. To accomplish this FDA must hold a public meeting months after the date of enactment of the Cures Act and issue guidance on, among other things, how to use such novel trial designs, how they can help to satisfy the substantial evidence standard, and recommended analysis methodologies.

Regarding Patient Access to Therapies and Information, Section 3036 is interesting: Standards for Regenerative Medicine and Regenerative Advance Therapies. This section requires the establishment of standards and consensus definitions to support the development and review of regenerative medicine therapies, including with respect to the manufacturing processes and controls of such products. In order to meet the requirements of the Cures Act, CBER will use innovation funds to facilitate a public process with the National Institute of Standards and Technology and other stakeholders to coordinate and prioritize the development of standards and consensus definitions of terms. Such standards and terms will help foster the development, evaluation, and review of regenerative medicine therapies, including with respect to the manufacturing processes and controls for such products. Innovation funds will support expert FDA staff engaged in this work, as well as help facilitate long-term engagement with stakeholders on regenerative medicine standards development and consensus definitions through the creation of a public-private partnership.

Regarding Medical Device Innovation plans, FDA writes about Section 3051: Breakthrough Devices. This section writes into law and expands FDA’s Expedited Access Pathway program, which allows for expedited development and review of devices that represent breakthrough technologies for life threatening or irreversibly debilitating diseases/conditions. The Breakthrough Devices program requires frequent and extensive interactions between device companies and FDA staff during the device development phase, as well as priority review for breakthrough medical devices. FDA estimates that this program will grow at a rate as high as 20 percent per year over the next 10 years. FDA expert staff will accommodate the increased workload and will need to acquire the IT systems needed to fully implement the program. The program will accelerate patient access to these lifesaving therapies.

FDA aims in another subsection of the document to outline its work to improve scientific expertise and outreach. Section 3073 relates to Intercenter Institutes. This section requires FDA to establish one or more intercenter institute(s) to help develop and implement processes for coordination of activities in major disease areas between the drug, biologics, and device centers. FDA has established the Oncology Center of Excellence (OCE) to create a unified policy approach and clinical review for all drugs, biologics, and devices used in medical oncology. It will leverage the combined talents and skills of all FDA regulatory scientists and reviewers who work in medical oncology product review.

OCE will also serve as a single point of contact for external stakeholders for our work in cancer, including professional societies and patient advocacy groups. FDA medical and professional staff will coordinate review of oncology product applications across the medical product centers, policy development, and collaboration with external stakeholders. This Center of Excellence will help expedite the development of oncology and hematology medical products and support an integrated approach in the clinical evaluation of drugs, biologics, and devices for the treatment of cancer.


The proposed FDA work plan describes activities that are intended to successfully achieve the Cures Act requirements in areas that are a high priority for any Innovation Account funding that is appropriated. Together with other funding sources, as available, FDA’s proposed Innovation Account funding allocations can help chart a path for advancing medical product development and reviews and help bring innovative new therapies and products to patients and health care providers in a more timely and efficient manner.


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