Life Science Compliance Update

April 20, 2017

FDA Public Workshop on Opioid Training

FDA-pills

The Food and Drug Administration (FDA) has announced a public workshop to obtain input on issues and challenges associated with federal efforts to train prescribers on pain management and the safe use of opioids.

The workshop has three major goals. First, participants will be asked to discuss the role that health care provider training plays, within the broader context of ongoing activities, to improve pain management and the safe use of opioids. Second, participants will be asked to comment on how best to provide health care providers, who prescribe or are directly involved in the management or support of patients with pain, appropriate training in pain management and the safe use of opioids. As a part of this discussion, current training efforts by States, hospitals and health care systems, Federal Agencies, professional associations and other groups will be considered in order to strategize how best to facilitate training for these health care providers. Finally, participants will also be asked about issues and challenges associated with possible changes to Federal efforts to educate health care providers on pain management and the safe use of opioids.

The public meeting, “Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics – Exploring the Path Forward,” is scheduled for May 9th and 10th, 2017, from 8:30 am to 5:00 pm on the 9th and 8:30 am – 4:30 pm on the 10th. The event will be hosted at the Sheraton in Silver Spring, Maryland.

Seating for this event is limited and the FDA may limit the number of participants from each organization. If you are interested in attending, either in person or via webcast, you can register here. Registration closes for the event on May 1, 2017.

During online registration, you may indicate if you wish to provide a statement during the Open Public Comment Period. The FDA will do what it can to accommodate requests to make public comments based on time allocated for public comment. Individuals and organizations with common interests are urged to consolidate or coordinate their comments, and request time for a joint presentation. Following the close of registration date, the FDA will determine the amount of time allotted to each commenter and the approximate time each oral comment is scheduled to begin; commenters should arrive ahead of their scheduled time in case the agenda moves ahead of schedule so as to be sure not to forfeit their speaking time. All requests to make oral comments must be received by the close of registration on May 1, 2017. No commercial or promotional material will be permitted to be presented or distributed at the public workshop.

If time and space permit, the FDA will allow for onsite registration on the day of the workshop, starting at 7:30 am.

Comments can be submitted either electronically or written by July 10, 2017.  

April 18, 2017

Will There Be an Uptick in FDA NDA Approvals This Year?

FDA-approved-525x340

Late last year, John Jenkins, director of the FDA’s Office of New Drugs told attendees at an event that the decline in new drug approvals (NDAs) was not due to a shift in FDA standards or policies. The number in 2016 (22) is remarkably lower than the total in 2015 (45). Could there be changes in 2017?

Report from event: Uptick in 2017?

Regulatory Focus reported from the Prevision Policy conference, quoting Jenkins directly: “There are fewer applications in front of us to act upon,” Jenkins said, noting that although he cannot discuss individual applications, a handful of the complete response letters (CRLs) issued in 2016 were due to good manufacturing practice (GMP) deficiencies and the need for FDA to conduct inspections. But Jenkins did say that there has been an uptick recently in the number of applications received, meaning the number of approvals could increase in 2017.

Recent news of an FDA approved drug to treat Parkinson’s disease lends some evidence to that claim. The drug, Xadago (safinamide), is an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes. An “off” episode is a time when a patient’s medications are not working well, causing an increase in Parkinson’s symptoms, such as tremor and difficulty walking.

MERIT Act

Introduced by Rep. Larry Loudermilk (R., Ga.), the Modern Employment Reform, Improvement, and Transformation (MERIT) Act, H.R. 559, would make it easier to “drain the swamp” by removing federal employees for poor performance or misconduct. The MERIT Act allows for due process: It requires notice in writing to the employee in question from the head of an agency and provides an opportunity to respond with an appeal. The Merit Systems Protection Board is required to issue a decision within 30 days of the appeal. 

The National Review suggests this Act could be quickly applied to the FDA. They argue: “In recent years, in both the formulation of policy and the evaluation of individual products, the FDA has made egregious errors and arbitrarily expanded its authority in extra-statutory ways that have had important consequences. Most of these missteps have been in the direction of excessive risk-aversion or heavy-handed regulation, although a few, such as oversight of herbal dietary supplements and compounding pharmacies, have been marked by laxity, timidity, or outright incompetence.”

It is unclear if this would increase the success rates of NDAs, but indicates the close intersection between the political environment, FDA policy, drug pricing, and even the regulators themselves.

Scott Gottlieb’s Impact?

President Trump’s nomination for FDA Commissioner, Scott Gottlieb, could result in faster approval of drugs as reported by the Hill. Gottlieb could introduce a new regulatory paradigm focused on competition to accelerate innovation, dramatically shorten the time from development to patient access, and sharply reduce the prices for new drugs. Rather than settling for the status quo that rewards delayed access and excessive caution, he can promote early access and fast learning.

April 11, 2017

Senate Holds Confirmation Hearing on Gottlieb

Scott Gottlieb MD WWSG Hi-Res Photo

On April 5, 2017, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a confirmation hearing on the nomination of Scott Gottlieb, M.D. to serve as Commissioner of the Food and Drug Administration (FDA). Members of the committee engaged Dr. Gottlieb on the agency’s role in addressing opioid abuse. Chairman Lamar Alexander of Tennessee said the Committee would vote on Dr. Gottlieb’s confirmation after the Easter recess.

During opening statements, Chairman Alexander called for quickly moving FDA user fee reauthorizations before Aug. 1. He said he is concerned with the Administration’s hiring freeze and its implications for the FDA, especially because the 21st Century Cures Act sought to bolster FDA staffing resources.

Ranking Member Patty Murray called for strong, independent leadership of the FDA and said Dr. Gottlieb has “unprecedented financial entanglement with industry.” She said she is concerned about potential ideologically driven decision-making, citing Bush Administration policy on women’s access to Plan B. She said she wants to hear Dr. Gottlieb’s plans for increasing competition through generics and biosimilars and reducing drug costs.

In his testimony, Dr. Gottlieb noted that he appreciates the agency’s work as both a doctor and a cancer survivor. He emphasized that he respects congressional intent and expressed desire to: assure timely implementation of laws, adhere to scientific rigor, and heed guidance from career staff. He said the agency must “lean forward” in implementing 21st Century Cures and that it is a “false dichotomy that everything is a balance between speed and safety,” adding that both are possible while adhering to “gold-standard regulatory conduct.”

Question and Answer Period

The question and answer period of the hearing was extensive, with conversation about many hot topics, including the hiring freeze, opioids, and conflicts of interest.

Hiring Freeze

In discussion with Chairman Alexander, Dr. Gottlieb said he understands how critical FDA personnel levels are and that it is “incumbent on us to have a world-class workforce.” Dr. Gottlieb said he has spoken out on staffing levels and will make it a priority. Chairman Alexander said he wants to make 21st Century Cures “a reality and [staffing and hiring] is an important part of it.”

Opioids

Opioid abuse was by far the most frequently raised and discussed issue of the hearing. Chairman Alexander asked about non-addictive painkillers, noting such options might be able to stem opioid abuse. Dr. Gottlieb said the epidemic has “staggering consequences” and will require an “all-of-the-above” approach, including “dramatic action.” He said that includes new alternatives, including device-based interventions and medication-assisted therapy (MAT).

Senator Tim Kaine discussed opioids with Dr. Gottlieb when Dr. Gottlieb said he would have a “bipartisan mandate” on finding the right framework for opioid policies and that opioids would be his “highest immediate priority.”

Conflicts of Interest

Dr. Gottlieb said he had thoroughly complied with Office of Government Ethics procedures and was committed to a “front office” process to mediating any ongoing concerns, including recusals. Senator Murray and other Democrats expressed numerous concerns about Dr. Gottlieb’s role in venture capital and as a board member and investor in various industry entities. Dr. Gottlieb said he is committed to earning the public’s trust.

Dr. Gottlieb has filed an ethics agreement stating that he will recuse himself for one year from any agency decisions that involve more than twenty health companies he has been connected to.

Biosimilars

Senator Mike Enzi asked Dr. Gottlieb about the status of approval of biosimilars. Dr. Gottlieb said there is an opportunity for “meaningful savings,” including through interchangeability. He expressed a need to get final interchangeability guidance out.

Competition and Reimportation

Senator Bernie Sanders asked about Dr. Gottlieb’s position on reimportation of drugs from Canada and cited Dr. Gottlieb’s writings on the approach not addressing “core challenges.” Dr. Gottlieb said he has other ideas on how to promote competition and that many of his articles may address subjects falling outside the FDA’s purview.

Trial Design

Responding to Senator Tim Scott, Dr. Gottlieb said he would encourage the use of better tools for getting products to market quickly. He pointed to Cures as a template, including “not just adaptive trial designs but modeling and simulation.” Senator Elizabeth Warren discussed the example of Thalidomide as illustrating the risks of prioritizing treatment over consumer protection. She questioned Dr. Gottlieb about his views on this balance and her concerns.

Senator Bob Casey asked about the role of Phase III trial data, saying Dr. Gottlieb had been critical of reliance on such results. Senator Casey said some safety issues arise only at that juncture. Dr. Gottlieb said it may be possible to compress Phase II and III into a larger adaptive design. He said a “proper clinical program is an essential feature and proper post-market enforcement tools are important.”

Industry Oversight

Senator Tammy Baldwin expressed concern with drug industry attempts to extend market exclusivity and engage in “misleading” direct-to-consumer advertising. Dr. Gottlieb said the FDA is designed to promote public health and not to engage in commercial disputes. He said he wants a “framework that prevents regulatory process’ use as commercial arbitrage.”

Conclusion

As noted above, the vote on whether to confirm Dr. Gottlieb won’t happen until the Senate gets back from Easter recess. However, Gottlieb has been endorsed by the National Consumers League, the National Coalition for Cancer Survivorship (he is a survivor of Hodgkin’s Lymphoma), the Global Healthy Living Foundation, the Alliance for Aging Research and by former FDA Commissioners Margaret Hamburg, Robert Califf, and Mark McClellan. It is likely that he will also be approved by the Senate to run the FDA, though it is likely that his appointment will fall along party lines in highly-partisan Washington, D.C.

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