Life Science Compliance Update

April 29, 2015

“Encouraging Continuing Medical Education For Physicians” Incorporated Into Newly Updated 21st Century Cures Discussion Draft

Notable updates to January's Draft include bipartisan concessions: New provisions to increase NIH funding; removal of provisions for increased exclusivity periods. 

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Today, the House Energy and Commerce Committee released an updated discussion draft of 21st Century Cures legislation (view the legislative text, whittled from 400 pages to 199 pages since January); a section-by-section explainer; and a 1-page summary). “The yearlong 21st Century Cures listening session explored the complete cycle of cures – from the discovery of clues in basic science, to the development of new treatments, to the delivery of those cures, and back again to further discovery,” the House notes in the press release for the new bill.

Unlike January’s release of the draft, which Democrats did not formally endorse, today's document  is issued as a bipartisan bill by Chairman Fred Upton (R-MI), Oversight and Investigations Subcommittee Ranking Member Diana DeGette (D-CO), Full Committee Ranking Member Frank Pallone, Jr. (D-NJ), Health Subcommittee Chairman Joe Pitts (R-PA), and Health Subcommittee Ranking Member Gene Green (D-TX).

Concessions: NIH Funding In; Market Exclusivity Out

One of the most notable new aspects of the bill—clearly evidenced as the lead off provision—is that the 21st Century Cures bill would raise NIH funding to $31.8 billion in 2016 and to $34.85 billion in 2018. The bill would also create an NIH Innovation Fund of $2 billion per year to support “precision medicine” and “young emerging scientists.”

Another important change is the absence of provisions which extended the marketing exclusivity. The January version of the bill included a 15-year marketing exclusivity for “dormant therapies,” defined as medicine that “is being investigated or is intended to be investigated for an indication to address one or more unmet medical needs…”  The old bill also sought more exclusivity for “New Therapeutic Entities” and “Orphan Products.” View Title 1, Subtitles L, M, and N in the old bill’s language, not found in the new version. 

Encouraging Continuing Medical Education for Physicians

Most interesting to Policy and Medicine readers likely concerns the status of the continuing medical education provision in the new bill. The language is updated considerably from the first go-round. 

Subtitle C—Encouraging Continuing Medical Education for Physicians:Exempting from manufacturer transparency reporting certain transfers used for educational purposes.  

Updates to the Sunshine Act reporting requirements are included in red. 

Transparency Reports and Reporting of Physician Ownership or Investment Interests, Sec. 1128G. [42 U.S.C. 1320a-7h]

(B) Exclusions.—An applicable manufacturer shall not be required to submit information under subsection (a) with respect to the following:

  • (iii) Educational materials that directly benefit patients or are intended for patient use, including peer-reviewed journals, journal reprints, journal supplements, and medical textbooks;
  • (xiii) In the case of a covered recipient who is a physician, an indirect payment or transfer of value to the covered recipient 
    • (I) for speaking at, or preparing educational materials for, an educational event for physicians or other health care professionals that does not commercially promote a covered drug, device, biological, or medical supply; or
    • (II) that serves the sole purpose of providing the covered recipient with medical education, such as by providing the covered recipient with the tuition required to attend an educational event or with materials provided to physicians at an educational event.

This language is much clearer than previously set forth. CME Coalition Senior Advisor, Andy Rosenberg, was encouraged by the language in the new bill, and commended the bipartisan effort set forth in the 21st Century Cures initiative.  

Sharing Off-Label Data and Social Media

Also of note, the original draft's provision encouraging FDA to consider a new regulatory approach to social media has been dropped from the final bill. This could be in recognition of the fact that FDA has agreed to align their guidances concerning scientific exchange with the First Amendment. 

This new bill includes an important section entitled "Facilitating Dissemination of Health Care Economic Information," which offers some regulatory leniency concerning communications with payors and formulary committees. This is especially significant given the more prominent decision-making role payors play in the current health care environment. 

Other Highlights in the Bill 

The Energy and Commerce Committee ran down a short list of provision highlights in the bill, which, in addition to increasing the flow of funds to NIH, also:

  • Incorporate the patient perspective in the discovery, development, and delivery process.
  • Foster development of treatments for patients facing serious or life-threatening diseases.
  • Repurpose drugs for serious or life-threatening diseases and conditions.
  • Modernize clinical trials.
  • Break down barriers to increased collaboration and data sharing among patients, researchers, providers, and innovators.
  • Help the development of personalized and precision medicines so the right patient can receive the right treatment at the right time.
  • Provide for continued work in the telehealth space.
  • Advance a truly interoperable health care system.
  • Provide clarity for developers of software products used in health management and medical care.

We will continue to cover this important legislation as it makes its way through Congress. 

October 22, 2014

Mining Social Media for Adverse Events

Twitter and Drugs

In February, the FDA released a Request for Proposal asking firms to help the agency monitor social media activity for adverse event reporting, among other content. Many have been critical about the utility of FDA examining user-generated content for adverse events. While such an effort may seem like a “needle in the haystack” approach, we think social media and online activity could lead to some fruitful information.


An “adverse event” is any serious undesirable experience a patient has associated with the use of a medical product. In the time after FDA approves a drug, unexpected safety problems can emerge once a product goes to market and is used widely among potentially millions of people. As a result, a critical aspect of FDA’s responsibilities includes postmarket safety monitoring—analyzing the risks and benefits of products once they go to market.

“The rise of social media on the Internet, including especially user-generated content such as blogs, forums, message boards, wikis and podcasts, has created new opportunities to interface with the public with respect to emerging hazard situations involving FDA-regulated products,” FDA states in their solicitation. “The increasing presence of social media promises new capabilities to monitor the effectiveness of FDA's ongoing risk communication efforts.” Thus, FDA noted that they are “in need of both historical and ‘real-time’ monitoring and analyses of a representative sample of social media web sites.”

FDA is especially interested in early detection of adverse events as well as food-borne illness. “The scope of work includes social media buzz reports, a social media dashboard, and quarterly surveillance reports related to specific product classes.”

New Study – More people report adverse events on Twitter than to FDA

FDA may be headed in the right place. A study entitled Digital Drug Safety Surveillance: Monitoring Pharmaceutical Products in Twitter released earlier this year suggests that patients are more likely to post drug-related adverse events on Twitter than report them to the FDA.

The researchers compared adverse events related to a diverse range of prescription and over-the-counter drugs identified in Twitter posts with corresponding data collected from the FDA Adverse Event Reporting System (FAERS). The study identified 4,401 reports with resemblance to adverse events, which they deemed “Proto-AEs,” among a sample of 61,402 posts collected from 6.9 million tweets sent between November 2012 and May 2013. In comparison, 1,400 adverse events (AEs) were reported to FAERS during a similar timeframe.

Twitter users can direct their conversations to specific medical products or government agencies. The authors note that Twitter hashtags to #Pfizer, #FDA, or on specific issues, such as “#accutaneprobz” show that patients are increasingly using Twitter in order to be heard.

For example:

“I don't understand it when people say they're always hungry. I can't even remember the last time I had an appetite #AccutaneProblems

The authors note: “[a]t the same time that there is significant under-reporting of AEs through official channels, new Internet services have given voice to patients who routinely share information in public forums, including their experiences with medical products,” note the authors.

As anyone who scans Twitter knows, often you have to work through a lot of garbage to land on meaningful information. The authors nonetheless believe Twitter holds very valuable information; the trick is to know how to search for it:

“One of the key aspects of this research was to develop an ontology that allowed translation between social media vernacular and MedDRA [Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary], yielding strong automated classification performance as noted above. As an illustrative example of this cross-ontology translation process, we consider the tweet “Humira never really worked for me. Orencia was good. Xeljanz was the best but ate a hole in my stomach. #RABlows.” In this example with rheumatoid arthritis medicines, the first product could be reported as ineffective, but there is also a more serious event.”

Others are not so sure

Depending on social media data mining for adverse event reports is a long shot, says Steven Nissen, MD, department chair of cardiovascular medicine and patient advocate with the Cleveland Clinic. Nissen was recently interviewed in HealthLeaders Media.

"This is like listening to rumors," he states. "Someone tells you something, you tell someone else, it gets repeated as fact." Tweets about the negative side effects of a specific drug could actually cause widespread misinformation about it.

Furthermore, due to privacy concerns, Nissen argues that "[d]octors aren't going to be tweeting adverse effects, and the Twitter Generation doesn't take too many drugs yet." Nissen concludes: “If the FDA wants to get better data about adverse reactions, it will be through improving their current reporting systems, not by listening to random chatter on the Internet." 

Industry duties to report adverse events

According to their 2001 draft guidance for industry entitled Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines, adverse event information submitted via the Internet to an entity with postmarketing reporting obligations should be reported to FDA if there is knowledge of the four basic elements for submission of an individual case safety report, namely:

  • 1. An identifiable patient
  • 2. An identifiable reporter
  • 3. A suspect drug or biological product
  • 4. An adverse experience or fatal outcome suspected to be due to the suspect drug or biological product

Because Tweets and Facebook posts arguably do not cover a number of these required categories, companies have sought further instruction from FDA about their responsibilities. FDA’s most recent release of social media guidance makes limited mention of companies' adverse event obligations. They focus instead on how companies must convey risks within 140-characters and what obligations companies have when correcting inaccurate Facebook and twitter posts


As more people turn to social media for medical information, it will be interesting to follow how both FDA and industry respond. With the breadth of disease-specific chat rooms and online forums, vital risks are certainly being discussed online. 

We are also interested in the potential for google searches to reveal important disease related information. Analysis of searches for particular symptoms within, for example, particular geographic areas, would offer useful information concerning the spead of disease. 

October 06, 2014

FDA Reopens Comment Period For Social Media Guidance; PhRMA and Washington Legal Foundation Weigh In

Social Media pics

FDA is reopening the comment period for its two controversial draft social media guidances. The decision comes in response to requests for additional time to allow interested parties to submit comments.

As stated in the Federal Register, starting on September 29, 2014, the public will have an additional thirty (30) days to provide comments on the following guidance documents: (1) Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (available here); and (2) Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (available here).

We wrote an extensive analysis on both guidance documents: the character space limit guidance, and the third-party misinformation guidance.

If you are interested in commenting on these guidance documents, submit electronic comments here for the Internet/Social Media Platforms with Character Space Limitations guidance document or here for the Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices guidance document.

Thus far, feedback from industry and user groups has been critical, especially comments from the Washington Legal Foundation and Pharmaceutical Research and Manufacturers of America (PhRMA).

In its comment, the Washington Legal Foundation urged the agency to rescind the draft character limit guidance, arguing it imposes severe restrictions on the right of drug and medical device manufacturers to use Twitter and other social media. The Foundation argues that FDA’s speech restrictions violate the manufacturers’ First Amendment rights and that less restrictive methods could be used to reach the FDA’s goals as opposed to total speech ban.

They wrote: “the gist of the draft guidance is that manufacturers should rarely, if ever, attempt to use Internet/social media platforms with character space limitations because those limitations do not provide manufacturers with sufficient space to include all the risk and benefit information that FDA asserts is a necessary part of any such communications.

“The de facto prohibition on use of such Internet/social media platforms is inconsistent with FDA's statutory mandate and raises serious First Amendment concerns regarding the rights of manufacturers to speak truthfully on important healthcare issues.”

Additionally, the Pharmaceutical Research and Manufacturers of America criticized FDA for its inconsistency:

"PhRMA and its member companies would like to highlight that FDA’s Draft Guidance is inconsistent with the agency’s own responsible communications about medicines using Internet and social media platforms with character space limitations. Specifically, FDA now uses character-limited platforms to announce information about drugs and does it in a responsible, truthful way, including providing safety overviews after Twitter links. Yet FDA proposes to restrict manufacturers from using the same social media tools that FDA uses. FDA’s own actions – including the use of links to present risk information and general descriptions of the benefits of drugs – provide reasonable standards for appropriate use of these media ... it cannot be truthful and non-misleading for FDA to use character-space-limited platforms in one way, but misleading for biopharmaceutical companies to do the same."


As we noted in our coverage of the guidances when they came out, FDA's document on correcting third party misinformation provided some specific answers to important industry interactions within social media. However, the "Twitter guidance" added little to the discussion. In most cases, 140-characters is an impossibly small amount of space to cover what FDA requires for many drugs.  We will be interested in following FDA’s response to feedback in the coming months. 


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