CDER’s Woodcock Says FDA Is Meeting GDUFA Challenges at House Pricing Hearing

Feb. 8, 2016 – At last week’s House hearing on drug pricing a bipartisan group of U.S. Congressional members, the press and much of the biopharma industry were focused on a public hanging of former Turing Pharmaceuticals CEO Martin Shkreli while the FDA offered quiet but compelling testimony on generic drug approvals.

Although the FDA has had challenges implementing the Generic Drug User Fee Amendments of 2012 (GDUFA), it now has met or exceeded all GDUFA performance goals, is well ahead of the goal to complete first actions on Abbreviated New Drug Applications (ANDAs) and is close to achieving the goal of eliminating the ANDA backlog, Center for Drug Evaluation and Research Director Janet Woodcock, M.D., said at the Feb. 4 hearing held by the House Committee on Oversight and Government to address drug pricing issues.

Woodcock attempted to assuage concerns raised by the committee members that delays in generic drug approvals are slowing down the entry of new, less costly generic drugs to the market and as a result are contributing to higher drug prices.

”The Woodcock testimony underlined two facts about the cost of drugs: (1) there are no easy answers; and (2) the FDA is doing its job on the generic approval side,” noted Coalition for Healthcare Communication Executive Director John Kamp.

Woodcock’s testimony states that as of Oct. 1, 2012, the backlog was 2,866 ANDAs and 1,873 Prior Approval Supplements (PASs), and that as of the end of 2015, the FDA had taken first action on 84 percent of ANDAs and 88 percent of PASs. “At this point in time, as FDA acts on one of the outstanding backlog applications, the ‘time to approval’ of such application will be recorded as, at minimum, 40 months (i.e., we now are three years and four months (40 months) into GDUFA implementation),” Woodcock said. “This does not explain the often-quoted 42 month approval time, which does not apply to post-GDUFA applications.”

For the post-GDUFA applications, for which there are no goal dates, the FDA has assigned internal goals, Woodcock explained. Applications submitted in fiscal year (FY) 2015 have a 15-month “first action” goal date, as do applications submitted in FY 2016. “So, any concerns about delayed competition in the generic space pertain to prior years, when our backlog was accumulating,” according to Woodcock. She presented a chart indicating that in December 2015, CDER ended with a monthly high of 99 approvals and tentative approvals.

She also explained in her testimony that the agency prioritizes certain types of applications, such as “first generics” – those that are the first generic version of a drug to enter a particular market. As of FY 2015, these submissions automatically receive a 15-month goal date. “Because they are public health priorities, we expedite their review, like an express lane at the supermarket,” Woodcock’s testimony stated.

Woodcock also shared with the committee that the FDA has been able to achieve these goals by restructuring and building a “modern generic drug program,” which includes reorganizing the Office of Generic Drugs and elevating it to “Super Office” status, establishing a new Office of Pharmaceutical Quality, developing an integrated informatics platform, and hiring more than 1,000 new employees. Further, CDER adopted a more flexible approach to managing its program by focusing on greater communication and transparency with industry, she noted.

However, Woodcock also described ongoing challenges that the agency is facing in the generics space:

  • Submission quality is lacking. Historically, it has taken an average of four review cycles to approve an ANDA as a result of deficiencies by generic drug sponsors in submitting complete and quality applications. She said that GDUFA II negotiations have included establishing a pre-ANDA process to allow FDA and sponsors to address issues prior to ANDA submissions.
  • There is a need for more research in the generics space, because for some drugs, there is “no convincing bioequivalence test method available.” Although GDUFA provided funding for such research, “scientific research takes time, and results will need to be translated into guidance for industry,” her testimony states.
  • Shared Risk Evaluation and Mitigation Strategies (REMS) can be problematic because brand and generic companies must agree on a system to assure safe use, which “frequently results in blocking generic competition.”
  • Additional quality regulation is needed to “better assure quality in an increasingly globalized industry.”

Woodcock concluded by stating that she is “extremely proud of what the FDA staff has accomplished in implementing GDUFA. Getting where we are today has taken an enormous amount of work and above-and-beyond dedication by many people over the past three years.”

For additional coverage of the House Oversight and Government Reform drug pricing hearing, see Policy and Medicine’s article at: