Life Science Compliance Update

July 25, 2017

New Report Releases Strategies to Reduce Opioid Epidemic

NationalAcademiesLogo1

The National Academies of Sciences, Engineering, and Medicine recently released a report, requested by the United States Food and Drug Administration, that highlights what can be done to stop the opioid use disorder and other opioid-related harms without closing access to opioids for patients who need them.

The committee that conducted the study and wrote the report recommended actions the FDA, other federal agencies, state and local governments, and health-related organizations should take – which include promoting more cautious prescribing of opioids, expanding access to treatment for opioid use disorder, preventing more overdose deaths, weighing societal impacts in opioid-related regulatory decisions, and investing in research to better understand the nature of pain and develop non-addictive alternatives.

In more recent years, national initiatives to reduce opioid prescribing have modestly decreased the number of prescription opioids dispensed. Unfortunately, many people who otherwise would have been using prescription opioids have transitioned to heroin use. According to the report, the declining price of heroin, together with regulatory efforts designed to reduce harms associated with the use of prescription opioids – including the availability of abuse-deterrent formulations – may be contributing to increased heroin use.

One approach to addressing the opioid epidemic is to have a fundamental shift in the nation’s approach to prescribing practices and improve awareness of the risks and benefits of opioids. Therefore, the committee recommended education for both health professionals and the public. Such education should involve mandating pain-related education for all health professionals who provide care to people with pain, requiring and providing basic training in the treatment of opioid use disorder for health care providers, and training prescribers and pharmacists to recognize and counsel patients who are at risk for opioid use disorder or overdose.  In addition, the lack of attention paid to educating the public about the risks and benefits of prescription opioids needs to be addressed. The report called for an evaluation of the impact and cost of an education program that raises awareness among patients with pain and the public.

The committee stressed that restrictions on lawful access to prescription opioids could have other unintended effects, and any policy designed to curtail legal access to them will inevitably drive some people toward the illegal market. Therefore, a strategy for reducing lawful access to opioids should be coupled with an investment in treatment for the millions who have opioid use disorder. 

The committee recommended that states – with assistance from relevant federal agencies, particularly the Substance Abuse and Mental Health Services Administration – provide universal access to evidence-based treatment for opioid use disorder in a variety of settings, including hospitals, criminal justice settings, and substance-use treatment programs. The U.S. Department of Health and Human Services (HHS) and state health financing agencies should also remove impediments to full coverage of medications approved by the FDA for treatment of opioid use disorder.

Several other strategies that the committee recommended include:

  • the FDA should complete a review of the safety and effectiveness of all approved opioids;
  • states should convene a public-private partnership to implement drug take-back programs that allow drugs to be returned to any pharmacy on any day, rather than relying on occasional take-back events;
  • public and private payers, including insurance companies, should develop reimbursement models that support evidence-based and cost-effective comprehensive pain management, including both drug and non-drug treatments for pain;
  • HHS, in concert with state organizations, should conduct or sponsor research on how data from prescription drug monitoring programs can be better leveraged to track opioid prescribing and dispensing information; and
  • the National Institutes of Health, the Substance Abuse and Mental Health Services Administration, the U.S. Department of Veterans Affairs, and industry should invest in research that examines the nature of pain and opioid use disorder, as well as develop new non-addictive treatments for pain.

June 11, 2015

AMSA Scorecard Provides Useful Conflicts of Interest Tool For Industry Compliance Professionals

 

AMSA Scorecard

Periodically since 2007, the American Medical Student Association (AMSA) has released a “Scorecard,” ranking medical schools on how strict their policies are regarding interactions between their students and faculty and the pharmaceutical and device industries. The AMSA Scorecard is decidedly anti-industry, but by consolidating all of the conflict of interest documents for schools around the country, the list is actually a very useful tool for compliance professionals who must be attentive to a wide range of university policies. 

This initial AMSA Scorecard graded medical schools simply on whether they had a policy regulating the interactions between their students and faculty and the pharmaceutical and device industries. In 2008, AMSA worked with the Pew Prescription Project, an initiative of the Pew Charitable Trusts, to develop an updated Scorecard, “which used a more rigorous and transparent methodology to assess the content of policies at medical schools throughout the country,” states AMSA. In 2014, the AMSA instituted “further changes to the scoring methodology that better assess the nuances of medical center and industry relationships.”  

Leading up to 2014, the "AMSA scorecard methodology working group reviewed the literature on conflicts of interest, including the recent recommendations published by the Pew Task Force on Medical Conflicts of Interest." As a result, AMSA changed the number of domains from 11 to 14 for medical schools, and 16 for teaching hospitals. AMSA focuses on conflict-of-interest policies directly related to industry marketing and education. While not addressed in the scorecard, "academic medical centers should also have robust policies to ensure the integrity of basic and clinical research," AMSA advises.

AMSA Scores

The domains AMSA rates are:

  1. Gifts from industry
  2. Meals from industry
  3. Industry-sponsored promotional speaking relationships
  4. Industry support of ACCME-accredited CME
  5. Attendance of industry-sponsored promotional events
  6. Industry-funded scholarships and awards
  7. Ghostwriting and honorary authorship
  8. Consulting and advising relationships
  9. Access of pharmaceutical sales representatives
  10. Access of medical device representatives
  11. Conflict of interest disclosure
  12. Existence of an adequate conflict-of-interest medical school curriculum
  13. Extension of COI policies to adjunct/courtesy faculty and affiliated hospitals/clinics
  14. Enforcement and sanctions of policies

For teaching hospitals, AMSA also scores on pharmaceutical samples and P&T committees. 


How Does AMSA score these domains?

Some of AMSA's decisions about "model" policies are worth noting (click on the image for a clearer view). 

AMSA Examples

 

On the topic of continuing medical education, hospitals get a “1” if they follow standards laid out by the Accreditation Council for Continuing Medical Education (ACCME). AMSA states: “Studies (of course they don't state what those studies are) have shown that industry funding of continuing medical education programs tends to bias topic choices and content in favor of the sponsors’ products and therapeutic areas.” Thus, to achieve a “model” policy ranking according to the AMSA scorecard, the policy would have to state “that industry funding is not accepted for the support of accredited CME courses except in certain clearly defined circumstances.”  Whatever AMSA defines them.

Other domains are similarly strict. For example, on the subject of pharmaceutical sales representatives, a “3” score would mean sales reps are not allowed any access to any faculty or trainees in academic medical centers or affiliated clinical entities. 

View AMSA's criteria for their various scores here

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Leading institutions such as the Mayo Clinic, Cleveland Clinic, and Ohio State University’s Wexner Medical Center, just to name a few, are given B ratings by the AMSA. While the score itself is not of much help to compliance professionals, AMSA  has put together a comprehensive and helpful resource for anyone who has to monitor and keep track of a potentially long list of COI policies at various medical centers and teaching hospitals. As pharmaceutical and device manufacturers must track and report virtually all of their interactions with physicians and teaching hospitals in a public database under the Sunshine Act, the industry must remain mindful of academic policies and various issues related to their collaborations with the entities. 

 

July 31, 2014

FDA Reliance on Draft Guidance for Significant Policy Changes under Pressure

In May, Senator Lamar Alexander (R-TN), the ranking member of the Senate HELP Committee, along with Senators Richard Burr (R-NC), Johnny Isakson (R-GA), and Orrin Hatch (R-UT), sent a letter to FDA Commissioner Margaret Hamburg "to express significant concern about [FDA's] use of draft guidances to make substantive policy changes." The letter notes that draft guidances are becoming default FDA policy, notwithstanding that they are issued for comment purposes only. Moreover, draft guidances are not revised, finalized, or withdrawn in a timely manner. 

Additionally, as previously reported, draft guidances often are the only information that the medical community, FDA-regulated entities, and FDA review staff may have on the agency's current position on important issues. Stakeholders feel constrained by the policy positions laid out in draft guidance, even (or perhaps especially) when those positions are inconsistent with consensus within the biomedical community-a fourth concern of the senators. In its September 2012 Report to the President On Propelling Innovation In Drug Discovery, Development, and Evaluation, the President's Council of Advisors on Science and Technology (PCAST) recommended, among other things, that the FDA rely on-and reflect the consensus of-the scientific community in developing and revising guidances. Despite this recommendation, however, the senators cited recent draft guidances by the FDA that did not incorporate recommendations by the international scientific community.

The letter requests FDA to respond to the following information requests and questions:

1. A list of all Level I Draft Guidances, including the date issued, and the timeline with which you plan to withdraw, revise, or finalize each guidance.

2. An update on Agency-wide activities to implement the "best practices" to make the finalization of guidance more efficient and expeditious, as discussed in the 2011 report Food and Drug Administration Report on Good Guidance Practices:  Improving Efficiency and Transparency.

3. Have you implemented the President's Council of Advisors on Science and Technology recommendation to rely more on the biomedical community in help developing and revising guidances, and if so, could you provide examples of specific guidances?

4. For the guidances still in draft form, how do you ensure your staff does not follow the guidance in the absence of any other policy or final guidance?

5. What is the average amount of time in calendar days that the FDA has taken to finalize draft guidances in the last five years?  What is the range?

Because these are all minority members on the HELP committee it will be interesting to see if the FDA ever responded to their requests.

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