Drug prices are moderating. Demand is set to skyrocket as Medicare Rx coverage for 40 million seniors begins. Regulators and
research organizations are exploring new ways to streamline drug discovery and development. Things should be looking up for
Instead, the picture is bleak: Safety concerns about Merck's Vioxx (rofecoxib) and antidepressants have expanded to include
a broad range of therapies. Newspapers are questioning whether the Prescription Drug User Fee Act has corrupted the drug approval
process. Prosecutors and plaintiffs' lawyers are hunting for evidence that companies knowingly promoted unsafe products. On
Capitol Hill, the powerful Senate Finance Committee is taking a renewed interest in drug regulatory issues, as Congressional
leaders plan investigations and hearings on industry practices and the "lax" FDA. And this month, state attorneys general
will meet to hash out strategies for tightening the screws on drug pricing and promotions.
Here are some areas where pharma can expect to feel the heat.
Who Controls Safety?
There is increasing support for the creation of a drug safety office independent of the drug approval process. Experts
say already-approved drugs should be reviewed again to ensure that Phase IV studies have been completed and to examine emerging
safety signals. Both the Institute of Medicine and the Government Accountability Office will be issuing reports on the effectiveness
of FDA's postmarket review system. They are expected to recommend increased spending on safety surveillance and product testing.
A likely funding source is the user fee program, which comes up for renewal in two years.
The Vioxx debacle is providing fodder for critics of DTC advertising. An FDA summary of the agency's own research indicates
that consumers don't really like drug ads and don't find them helpful in making healthcare decisions. In recent months, FDA
has criticized industry promotional activities in a flurry of warning letters, and the agency is under pressure to scrutinize
DTC advertising more closely to ensure that marketers fully address safety and risk issues. FDA's long-awaited final rule
revising professional labeling for drugs is slated to emerge "soon," and will help shape changes in the format and content
of ads and materials providing drug information.
Safety concerns will also intensify efforts to expand public access to clinical trial listings and study results. Congress
is weighing legislation to mandate broader disclosure of both negative and positive research outcomes, even though industry
has proposed a voluntary listing program. In a related move, the National Institutes of Health (NIH) is completing an initiative
to allow public access to the results of all NIH-funded research. Medical journal publishers oppose the NIH policy and are
countering with a plan to post hundreds of journal articles on a public website.
Innovation Takes a Back Seat
Until a few weeks ago, the top spot on FDA's priority list was the agency's effort to lay out pathways to speed more new drugs
to market. Now the turmoil about safety is raising fears of tighter drug approval policies and curbs on R&D. Agency officials
recently acknowledged some slowdown in the process of turning the March 2004 Critical Path report into new models for drug
research and development. Lack of funding may hamstring FDA collaborative efforts with industry and private research organizations.
In addition to these hot topics, industry and FDA face a broad range of health care issues in coming months:
Vaccine shortages. The unexpected shutdown of Chiron's Liverpool (UK) flu vaccine manufacturing facility in October and the resulting shortage
of flu vaccine for this winter continues to focus public attention on vaccine research and regulation. Some members of Congress
are blaming FDA for failing to enforce manufacturing standards or to recognize earlier the severity of the problems at Chiron's
plant. Prospects are dim that Chiron will regain its license in time to get back into production by March, so policy makers
will be looking for ways to encourage manufacturers to enter the US flu vaccine market.
FDA recently gave emergency approval to GlaxoSmithKline's vaccine, prompting GSK and other firms to weigh possibilities for
expanding sales to the United States. For the long term, HHS may offer grants to support research on new vaccine manufacturing
methods while Congress weighs tax incentives for new plant construction, government guarantees to buy back unused vaccine
doses, and legislation to reduce the threat of liability charges against vaccine manufacturers.