The United States could double the number of new prescription drugs available to consumers each year if it adopts an approach to more quickly review the medicines, a White House panel suggested Tuesday.
The President’s Council of Advisors on Science and Technology (PCAST) said the key to bringing more drugs to market is the utilization of the U.S. Food and Drug Administration’s accelerated approval program. The FDA established this program to fast-track drugs that treat serious illnesses or fulfill unmet medical needs. Such drugs receive conditional approval pending confirmatory trials. If post-market clinical trials demonstrate a drug is effective, it receives traditional approval. Otherwise, it is removed from the market.
The accelerated approval program has been used since the 1990s, first for treating AIDS and now cancer, The Wall Street Journal reports.
Expedited Review and Target Populations
The PCAST group of prestigious industry leaders also recommends that the FDA speed the approval of certain drugs and limit them to target populations. For example, a weight-loss drug may be aimed at and approved only for people who are morbidly obese, not those who only have a few pounds to lose. This would allow for smaller and shorter clinical trials, leading to a faster review period.
The problem is that once a drug is approved through current FDA methods, its uses are not restricted. Doctors can prescribe drugs for so-called off-label purposes. (Manufacturers, though, are not allowed to promote those uses, unless the FDA grants approval.) So, how would the FDA police the use of such drugs?
According to Science Insider, the PCAST panel is proposing a “special medical use” label on the specialized drugs to help keep physicians on track with their intended use. But the reality is that the FDA would have to step up its post-marketing surveillance efforts.
And that means more manpower, something the FDA already is struggling with. The Medical Device User Fee & Modernization Act, which would help pay for more FDA scientists, was approved for renewal in August. But conflicts with the federal budget, to which the user fees are tied, could decrease the funding in January. The already overworked agency cannot keep up with the growing workload of reviewing drugs and medical devices — even without this latest proposal.
Serious Side Effects and Complications
Furthermore, the number of drugs linked to serious side effects and life-altering complications after they are approved has exploded in recent years. And many of those drugs were approved through the long, arduous process the FDA has in place — not the expedited process that is being proposed.
The Wall Street Journal notes that Thomas J. Moore, director of the drug-safety publication QuarterWatch, said the report “recommends exposing more patients earlier to new drugs that have not yet undergone complete testing” and called that a “health gamble.”