- The Washington Times - Sunday, April 27, 2003

That the drug-approval process can and must be improved is not in doubt. We examined some of FDA Commissioner Mark McClellan's proposals to that end in the last editorial in this series. However, there are additional measures that Dr. McClellan might want to consider, and Congress also has a role in this reform.
Actually, Congress has already acted. Last term, it renewed the Prescription Drug User Fee Act (PDUFA), under which those pharmaceutical companies sponsoring new drug applications pay the FDA a user fee that the agency uses to hire additional reviewers. Since the act was passed in 1992, the FDA has hired more than 1,000 reviewers and reduced drug approval times.
Congress has also done a decent job in setting up the statutory framework for generic drugs. While some Democratic senators have alleged that frivolous lawsuits filed by pharmaceutical companies to protect their drug patents have so slowed the arrival of generics that amendments to the law should be made, the FDA already has a rule in development that should answer many of those concerns. Besides, such lawsuits do not appear to be a major reason for the low availability of some generics, and firms that make generics have proved adroit in poking loopholes in pharmaceutical patents.
Perhaps most urgently, Congress must act to provide the proper long-term financial incentives needed for the development of bioterrorism countermeasures. As observed in the first part of this series, companies that might be inclined to develop such countermeasures have to do so with no guarantee that there will be a market for them consumers only became interested in Cipro after anthrax started showing up in envelopes, and the administration lacks the authority to purchase countermeasures whose delivery might be up to a decade away.
President Bush's proposal, Project Bioshield, should eliminate these disincentives by guaranteeing the purchase of successfully developed countermeasures. The bill (S. 15) would also enable the FDA to make potential treatments speedily available during an emergency. It passed unanimously though the Health, Education, Labor and Pensions Committee earlier this year, and it would have probably passed the entire Senate before the Easter recess had it not been held up by Sen. Robert Byrd.
Some senators do not believe that Project Bioshield goes far enough. Sens. Orrin Hatch and Joe Lieberman have co-sponsored a much more comprehensive measure (S. 666), which would provide tax credits to companies researching countermeasures; set up a guaranteed market for them; allot them some intellectual property protections; and even establish liability provisions. While that might be worth looking into, we'd prefer that Congress first pass Project Bioshield.
Another area in which Congress could speed the approval process is to offer financial incentives and provide liability protections to companies participating in compassionate use programs. Those programs permit drug makers to provide promising, unapproved pharmaceuticals to desperately ill patients who do not qualify for clinical trials. Since such drugs are often the only hope of ailing individuals, the organization called Abigail Alliance for Better Access to Experimental Drugs has argued that the FDA should grant provisional approval to such medicines.
The Competitive Enterprise Institute has gone even further, proposing that the FDA simply certify drugs rather than having any veto authority over them. In the paper "A Modest Proposal," the institute argues that physicians ought to be allowed to prescribe unapproved therapies so long as patients provide their informed consent.
That seems to go a bit too far, since the FDA has done a decent job of making drugs safe, but not always at a reasonable speed. To that end, Dr. McClellan must continue to insist that his agency set clear, consistent safety standards throughout the approval process. Those in the risky business of developing new drugs deserve to have the regulatory boundaries clearly defined at the beginning of the process.
Safety baselines should also be set in a transparent manner. Currently, pharmaceutical companies are not even allowed to ask for regulatory guidance while drugs are being developed. This must change. Drug companies should be given permission to request and receive regulatory guidance from the FDA throughout the approval process. While the privacy concerns of pharmaceutical companies should be respected, those requests and their answers should also be available to the public.
Dr. McClellan should also move the FDA toward requiring less paperwork in the drug-approval process. Astonishingly, the agency still requires that all drug approval forms be filed on paper. Not so long ago, many of us filed our 1040s electronically. If electronic forms are good enough for the IRS, they ought to be good enough for the FDA.
Both congressional action and commissioners' orders improve the drug-approval process. It simply must adapt to the ongoing revolution in biotechnology. In the last part of this series, we'll look to the future.

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