By Kurt R. Karst –
Earlier this week, the U.S. Senate passed, by a 69-30 vote, H.R. 2112, the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2012, as part of an omnibus package of three spending measures. The House and Senate versions of the bill differ, and those differences will need to be ironed out before FDA is funded for Fiscal Year 2012. Several Senate amendments to H.R. 2112 were considered and rejected, including Sen. David Vitter’s (R-LA) Amendment No. 769 to permit individuals to reimport drugs from Canada, and Sen. Jim DeMint’s (R-SC) Amendment No. 763 to prevent FDA from using funding to phase out by 2012 OTC epinephrine metered dose inhalers that contain chlorofluorocarbons. Other amendments were not considered or voted on, including Sen. Lisa Murkowski’s amendment to prevent FDA from using funds to approve genetically engineered fish, and Sen. Jeff Sessions’ amendment to prevent the U.S. Patent and Trademark Office from using funds to implement Section 37 of the Leahy-Smith America Invents Act concerning patent terms extensions (see our previous post here).
One amendment that passed the Senate gauntlet and that caught our attention is Sen. Richard Burr’s (R-NC) Amendment No. 890, which is intended to “improve the transparency and accountability of the FDA in order to encourage regulatory certainty and innovation on behalf of America's patients.” The text of the amendment states:
Provided further, That not later than 90 days after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to Congress a report that discloses, with respect to all drugs, devices, and biological products approved, cleared, or licensed under the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act during calendar year 2011, including such drugs, devices, and biological products so approved, cleared, or licensed using funds made available under this Act: (1) the average number of calendar days that elapsed from the date that drug applications (including any supplements) were submitted to such Secretary under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) until the date that the drugs were approved under such section 505; (2) the average number of calendar days that elapsed from the date that applications for device clearance (including any supplements) under section 510(k) of such Act (21 U.S.C. 360(k)) or for premarket approval (including any supplements) under section 515 of such Act (21 U.S.C. 360e) were submitted to such Secretary until the date that the devices were cleared under such section 510(k) or approved under such section 515; and (3) the average number of calendar days that elapsed from the date that biological license applications (including any supplements) were submitted to such Secretary under section 351 of the Public Health Service Act (42 U.S.C. 262) until the date that the biological products were licensed under such section 351. [(Emphasis added)]
Sen. Burr, along with Sen. Tom Coburn (R-OK), have long criticized FDA, saying that the Agency‘s “regulatory malaise” harms patients and manufacturers. That was the message in a commentary piece that appeared in The Washington Times in February 2011, titled “Caution kills – FDA’s go-slow approval approach shortens lives.” More recently, Sen. Burr criticized FDA for the Agency’s lack of speedy approvals during a July 2011 Health, Education, Labor and Pensions Committee hearing on user fees. He also threatened to delay the passage of FDA reauthorization bills, like the Prescription Drug User Fee Act (“PDUFA”) and the Medical Device User Fee and Modernization Act (“MDUFMA”), unless the Agency speeds up approval times. Referring to FDA-Industry PDUFA and MDUFMA negotiations, Sen. Burr commented “I‘m somewhat bewildered that both industries even sat down and talked about this process” given the delays in approval decisions. Some in Congress have expressed their intent to reauthorize PDUFA and MDUFMA, and to pass a host of other FDA-related measures, such as the Generic Drug User Fee Act, well before the end of Fiscal Year 2012.
The criticism of FDA’s review processes and approval times is not unique to Congress. Last month, the National Venture Capital Association’s MedIC Coalition issued a report, titled “Vital Signs: The Threat to Investment in U.S. Medical Innovation and the Imperative of FDA Reform,” fingering FDA as the culprit for decreasing venture capitalist investments in U.S. drug and medical device companies.
Provided Sen. Burr’s amendment is enacted as part of an FDA appropriations package, the information provided by FDA – within 90 days of enactment and perhaps right in the thick of user fee discussions on Capitol Hill – could provide the Senator with additional fodder to call for changes at FDA.
The focus of Sen. Burr’s amendment is on the number of calendar days to approval, rather than on the FDA goal dates aspired to under the user fee statutes and performance goals. For example, under PDUFA IV, FDA’s goal is to review and act on 90% of standard NDAs and BLA within 10 months of submission and within 6 months for a priority submission. (Similar goals have been proposed for the fifth iteration of PDUFA.) Once FDA acts on an application, for example, by issuing a complete response letter identifying certain issues that need to be addressed for the Agency to grant final approval, the PDUFA “clock” stops. It could be months or years until those issues are fully addressed in a resubmission – which triggers a new resubmission goal date – and approval can be granted.
There is no user fee “clock” for ANDAs – at least not yet. Nevertheless, the Burr amendment requests information on all applications submitted under FDC Act § 505. The numbers for ANDAs, once provided by FDA, may pale in comparison to the NDA/BLA numbers. The current median approval time, which runs from application submission to approval (tentative or final), has been pegged at about 33 months.
Information on the number of calendar days that have elapsed between application submission and approval could give Sen. Burr and other Members of Congress a better sense of the efficiency of the FDA review process and whether it needs to be changed.