Everyone talks about FDA making decisions based on science, but politics clearly run the show. The new leaders on Capitol
Hill are rattling their price-control sabers as new studies emerge questioning the costs and benefits of newer medicines.
Even if Congressional leaders fail to repeal the Medicare non-interference clause, industry execs will be kept busy with questions
about research methods, too-high prices, and promotion practices.
Similarly, the anticipated Congressional free-for-all on the Bush administration will put FDA officials in the hot seat. There
will be hearings on inadequate oversight of drug safety, conflicts of interest, importing, lax enforcement, and hasty approvals.
Senators on both sides of the aisle attempted to block confirmation of Andrew von Eschenbach, before he was officially named
commissioner on December 7. They wanted to pressure FDA to approve a product, pull something off the market, permit drug imports,
or disclose information on confidential investigations.
Meanwhile, the Supreme Court is weighing a case on patent law, which could have major ramifications for the protection of
biomedical intellectual-property rights. Most pharma companies support the current approach, but small innovators may benefit
from a new interpretation.
Safety Over All
Drug safety is the prime driver behind a broad range of initiatives affecting the pharmaceutical industry. The demand for
safer medicines is spurring new R&D methods based on genomics and biomarkers. It is generating calls to curb drug advertising
and to adopt electronic information systems for identifying safety problems more quickly.
The drug safety banner also provides a rationale for opposing looser curbs on drug importing. Congress approved a measure
last year that permits individuals to import drugs from Canada, and broader import proposals will continue to gain a hearing
on Capitol Hill and in state houses.
Stonewalling on Safety?
A top priority for Congressional leaders is to enact drug safety legislation now that the Institute of Medicine has issued
its recommendations for dealing with the problem, and negotiations have begun to reauthorize the Prescription Drug User Fee
program (PDUFA). Senators Ted Kennedy (D-MA) and Mike Enzi (R-WY) have a bipartisan measure that calls for stronger controls
on the use of high-risk therapies, a more powerful drug-safety oversight board, curbs on drug advertising, more disclosure
of clinical trial results and penalties for failure to complete post-approval studies—but not an independent drug-safety office,
as others advocate. Kennedy and Enzi held a hearing on the proposal last November to jump-start deliberations.
At the same time, FDA's deputy commissioner of medical and scientific affairs, Scott Gottlieb, gave a speech mapping out the
agency's preferred approach to improving drug safety. Gottlieb emphasized the need for better information on medication effects,
more analytical tools to evaluate safety signals, and improved FDA communication about potential safety problems. He wants
to tap user fees to provide more resources for drug safety oversight, but cautioned that too many post-marketing risk-management
plans could be burdensome for health professionals.
To keep unsafe and counterfeit medicines out of the United States, FDA is escalating its campaign against drug counterfeiting
and ramping up efforts to protect the prescription-drug supply chain. Congress is considering legislation to stiffen penalties
on drug counterfeiters, and FDA is opening more investigations of these operators.
FDA also seeks to implement its long-delayed rule that requires certain wholesalers to maintain pedigrees on the drugs they
distribute, but small wholesalers have gone to court to delay implementation. Meanwhile, anti-counterfeit efforts are moving
on the international front. The World Health Organization has launched a drive to halt the surge in counterfeiting in developing
nations. The need for more cooperation among regulatory agencies to battle fake drugs was the most-discussed issue at a November
international summit of directors of medical products agencies.
Next Up: Unapproved Marketing
The drive for drug safety also is prompting a crackdown on unapproved medicines. FDA has escalated its attack on large-scale
drug compounding, charging large commercial compounders for marketing unapproved products.