How "Clean" Will PDFUA V Be? Rep. Pitts Explains His Vacuuming Technique
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Pennsylvania Republican Joe Pitts, chairman of the House Energy and Commerce Health Subcommittee, has a straightforward approach to reauthorizing the Prescription Drug User Fee Act – get it done early. The first priority is to ensure that the president signs PDUFA V into law by June of 2012, he said in an exchange with “The Pink Sheet” on his legislative priorities.
That goal is three months before PDUFA IV expires and gives Congress about 10 months to evaluate the PDUFA V agreement that FDA has negotiated with industry and is scheduled for initial release Sept. 1. The final version of that proposal will be sent to Capitol Hill Jan. 15 following a hearing and the opportunity for public comment. Pitts is open to a discussion of the many issues that could come up during review of PDUFA V by the health panel, which is where the legislation will originate in the House (Also see "What’s In A PDUFA Reauthorization? Maybe These Issues…" - Pink Sheet, 11 Jul, 2011.). The subcommittee began its exploration of potential PDUFA V issues with a July 7 hearing on how FDA’s drug review process affects innovation and investment in the biomedical industry (Also see "Woodcock Defends Speed Of FDA Reviews, Cites 20 Approvals In First Half Of 2011" - Pink Sheet, 7 Jul, 2011.). But whether those discussions will lead to legislative action within the tight timeframe envisioned for the legislation remains to be seen. No Deadline Crunch "The Pink Sheet": What are your priorities for subcommittee action related to FDA? Pitts: The subcommittee’s priority related to FDA is ensuring the Prescription Drug User Fee Act and the Medical Device User Fee Act are signed into law by June of next year. This will be the first reauthorization of these programs that has occurred during a presidential election year and we do not want to see the reauthorization of these programs derailed by delaying a final bill until September of next year. TPS: What changes to the way FDA regulates drugs and operates would you like to see and why? Pitts: It is probably premature to say what changes are necessary. We have not yet seen the PDUFA V agreement and we had our first hearing on the issue on Thursday [July 7]. The hearing was designed to educate members about the problems and challenges related to drug approvals that currently exist. Through anecdotes from patients and companies and reports, like the one from the California Healthcare Institute, we have learned that America is falling behind because of the lack of consistency and predictability at FDA and delays in the approval process. If this is true, we need to find out why and address it. America becoming a follower and not a leader in drug development is bad for our economy and bad for American patients. TPS: Will these issues be addressed in stand-alone legislation or be added on to reauthorization of the Prescription Drug User Fee Act during debate on its renewal in 2012? Pitts: Most likely these issues will be discussed during the reauthorization of PDUFA. However, I reiterate the commitment to get the PDUFA reauthorization done earlier, rather than later, next year. Speeding Drug Approval TPS: There have been suggestions that FDA has become too risk averse in its review of drugs and this deters innovation by industry and delays patient access to medications. Do you agree, and if so, how should it be remedied? Pitts: I have heard those criticisms, and they concern me. Much of this is a cultural issue at the agency. Reviewers and staff at the agency have been beaten down over the past five years in the press and in Congress. They are human, and they hear criticism. That culture change must come from leadership at the FDA, but also from Congress so the whole agency, from top to bottom, understands that we support its mission of getting life-saving therapies to patients. I am hopeful that some of the provisions being considered in PDUFA V will provide more consistency and predictability to the drug approval process and allow new drugs to get to patients quicker. TPS: Several stakeholders have suggested that FDA change its evidentiary standards to facilitate approval of needed drugs – the Biotechnology Industry Organization has suggested that FDA look at all the available evidence, not just randomized controlled trials, when assessing efficacy [ (Also see "BIO’s "Big Ideas" For FDA Reform Are Too Big For PDUFA" - Pink Sheet, 4 Jul, 2011.) ] and the National Venture Capital Association is suggesting that for drugs designed to treat an unmet medical need, approval should be allowed when the totality of evidence suggests a reasonable likelihood of patient benefit [ (Also see "FDA Approval Standards Need To Be Relaxed, Venture Capitalists Say" - Pink Sheet, 11 Jul, 2011.) ]. Are these suggestions under consideration by your panel and how do you think FDA should view the evidence? Pitts: I haven’t reviewed these proposals so I can’t comment on the substance, but I do think the committee should examine ways to expand the accelerated approval pathway as it seems to have worked well in stimulating innovation in oncology. New Authorities TPS: What new authorities, if any, do you think FDA needs to improve its oversight of imported drugs and ensure the safety of active pharmaceutical ingredients? Do you plan to consider legislation in this area? Previous proposals have included fees (in one version they totaled as much as $300 million/year) on importers. Is that something you would consider? Pitts: Many of the proposals that have been suggested seem to be authorities that FDA currently possesses. Some have discussed the need for manufacturers to have a better understanding and security of their supply chain of ingredients. That makes sense if done right, but we do have questions about whether the agency currently has this authority, and, if they do, why they have not exercised it. TPS: What about fees on generic drug companies? Those are being negotiated by FDA and generic drug makers but are not yet authorized [ (Also see "Generic User Fee Talks: Performance Metrics For Early Years Still Unresolved" - Pink Sheet, 11 Jul, 2011.) ]. Do generic user fees offer a viable funding alternative to improve FDA operations (a goal of industry) or do they contravene Republicans’ opposition to raising taxes? Pitts: If it is a true user fee, where the agency and the regulated party agree to a fee in return for a particular service or goal, then it is not a tax. There is a backlog of generic applications. It doesn’t help the generic company when its application sits at the FDA, and it doesn’t help patients who must wait for generic versions of drugs. If they come up with an agreement that works for both sides, then we will consider it. TPS: Rep. Phil Gingrey [R-Ga.] introduced legislation last month to provide incentives for companies to develop antimicrobials to treat drug-resistant microbes [ (Also see "Antibiotics Could Get Double Exclusivity Under House Bill; FDA Makes Its Own Moves" - Pink Sheet, 20 Jun, 2011.) ]. Will that be the subject of hearings or otherwise be considered? What do you think of his proposals? Pitts: I think Dr. Gingrey’s proposal has a lot of merit. Last year, the Health Subcommittee heard repeatedly about the lack of new antibiotics being developed. I would hope to have a hearing on his proposal later this year, but his work does deserve to be discussed and considered as we move forward with FDA legislation next year. No Independent FDA, Biosimilars Redux TPS: What is your opinion of removing FDA from HHS and transforming it into an independent agency and/or setting a fixed six-year term for the administrator? Pitts: Removing the FDA from the Department of Health and Human Services is not a solution to any problem. If there are structural or cultural issues at the FDA, those would exist whether or not the agency remained under HHS or became an independent agency. If there are problems, they must be identified and addressed. Window dressing of designating [FDA] as a separate agency does not do that. I know some people are beginning to advocate for a fixed six-year term for the FDA Commissioner. I would need more convincing. I have reservations that a fixed six-year term could insulate the FDA Commissioner from accountability. TPS: What is the likelihood that the Health Subcommittee will revisit biosimilars provisions of the healthcare law to shorten the data exclusivity period? What, if any, other changes to the biosimilars provisions are being considered? Pitts: None. The vote in the Energy and Commerce Committee was overwhelming. We approved the Eshoo-Barton amendment 47-11 [ (Also see "Follow-On Biologics: Defeat For Waxman, Win For Health Reform" - Pink Sheet, 31 Jul, 2009.)]. It seems pretty clear where the members of the Committee are. |
