Life Science Compliance Update

April 20, 2017

FDA Under Pressure to Speed Up Generic Approvals

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As has been reported, the FDA is under pressure to speed up approval of generic medicines. In response, the FDA released data indicating its actions on the approval of generic medication. However, as noted by NPR in one example consumers and lawmakers pushing for cheaper alternatives to the EpiPen and other high-priced medications are seeking answers about what they describe as a “stubborn” backlog.

FDA’s response

In Kathleen Uhl, MD’s presentation (Director, Office of Generic Drugs at CDER within FDA), she stated the agency is meeting all of its obligation under GDUFA and even going above and beyond its commitments. FDA states it is “building a modern, 21st Century generic drug program,” which is resulting in “significant and sustained increases in communications, actions & approvals.”

According to numbers from FY2016, FDA approved 190 generic drugs with tentative approval to 48. December 2016 was the highest number of approvals and tentative approvals in one month ever for the FDA at 99. CY2015 broke the record for the highest number ever in a year at over 700+.

To continue building the FDA’s operations, Uhl stressed an interested in foundational restructuring, the building of more internal FDA infrastructure, improvement of business processes, hiring and training more staff, a new IT platform, and improved communications. Regarding IT improvements, FDA says it improved communication and increased productivity—a direct result of its improved IT system for the generic drug program. This provides the agency with workload management and review management tools. They have assigned over 130,000 items in this new platform.

The presentation offers a lot of data which is worth reviewing. However, it also stresses there is “no filing backlog” and that filing is currently done in “real time” (31 days). The first step in review is filing. Something acceptable for filing means the application is sufficiently complete to permit substantive review. It does not mean it will be approved.

Industry response

As reported by Stat: “Overall, there’s some improvement,” said Robert Pollock, a former acting deputy director of the FDA Office of Generic Drugs, who now works at Lachman Consultants and advises drug makers on regulatory matters. “But the question is can it be sustained, and will there be progress beyond what we’ve seen.”

Stat explains that generic drug approval is getting more attention due to the national debate over drug costs. Generics now account for 88 percent of all prescriptions written in the United States, according to IMS health. As a result, FDA’s leadership has stressed its work on accelerating generic approvals. And as Stat notes, Adam Fein of Pembroke Consulting, who tracks pharmaceutical distribution, contends the increasing number of approvals is starting to temper the price hikes for generic drugs. But historically, the FDA has been unable to keep up with the pace of marketing applications filed by generic drug makers.

Next GDUFA

Regulatory Focus notes that the median time to market has fallen considerably as GDUFA has progressed. For the fastest 5% of ANDAs approved under GDUFA, the median approval time has gone from about 24 months in FY 2013 to less than 15 months in FY 2015. However, under the next iteration of GDUFA, which will take effect in FY2018, ANDA standard review time will likely be 10 months from submission and priority review would be eight months from submission.

This is compared to the 42- to 44-month average approval time before GDUFA was in place. However, ANDA submissions do continue to outpace approvals and criticism of the median approval times does seem warranted according to Regulatory Focus, when considering that it takes FDA only 10 months to review and approve much more complex new drug submissions.

FDA Public Workshop on Opioid Training

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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?

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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.

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