Open Season on FDA - Pharmaceutical Executive


Open Season on FDA
Congress is firing plenty of ammunition at pharma companies—and the regulators

Pharmaceutical Executive

Even though FDA's budget is a tiny drop in the federal-spending bucket, it will be tough for Congress to expand it very much. The administration's $3 trillion 2009 budget attempts to keep its deficit below the $400 billion mark by curbing Medicare and Medicaid spending and freezing outlays for most discretionary programs. The National Institutes of Health is basically flat-lined, and there's a hefty cut proposed for the Centers for Disease Control and Prevention and others.

Congressional leaders say this last Bush budget is even more dead on arrival than previous versions. Democrats blasted defense increases, tax cuts for the wealthy, and the proposals to reduce healthcare and other services for the elderly and poor. No one expects big cuts in Medicare during an election year, so there will be a desperate scramble for any available funds to shore up federal government programs one more year.

Little Trust

FDA's larger problem is that many influential members of Congress either don't trust the agency to monitor the industry appropriately or have found it politically expedient to keep sounding alarms about inadequate oversight of food and drug safety, research, marketing, and pricing. House appropriators killed the DTC-advertising user fee largely because they don't believe that FDA regulates drug advertising forcefully enough. And they nixed the Reagan-Udall Foundation because of fears it will permit pharma to exert more influence on agency research programs. There are continual complaints about conflicts-of-interest among advisory committee members, which further taints agency advisors.

Congressional leaders also are unhappy with the Bush administration's continued support for federal preemption of state laws involving drug labeling and regulation. While federal preemption makes sense to anyone marketing a regulated product on a national basis or conducting clinical trials at multiple sites, challenges to state laws, in the current political climate, appear to undermine consumer protections at the local level. And they block lawsuits against the industry.

Key Democrats in the House and Senate are calling for legislation in response to the recent Supreme Court decision (Riegel v. Medtronic) that supports FDA preemption of state medical-product regulation. Although the Justices ruled 8 to 1 that FDA-approved medical devices are protected from personal injury suits at the state level, Democrats insist that such blanket protection was not the intent of Congress. The high court is slated to rule later this year on whether preemption applies similarly to injuries related to drugs, which is less clear under the current statute.

Federal preemption was a controversial issue in crafting the FDA Amendments Act last year. The issue recently reared up over an FDA proposal to clarify when manufacturers can file changes-being-effected (CBE) supplements to quickly make labeling changes involving new drug-safety information. House and Senate leaders objected that the proposed rule actually would give pharmaceutical companies a rationale for hiding drug safety information and would shield marketers of unsafe products from legal action.

Meanwhile, states are enacting laws that aim to curb pharmaceutical-marketing activities. The rationale is that reduced spending on drug detailing and advertising will lead to lower drug prices, a fairly tenuous link. California and Vermont want to restrict the ability of drug marketers to access physician-prescribing information. A Maine law undermines detailing.

Some of these restrictive policies have been challenged as violating free speech rights. But the proliferation of marketing curbs by state governments, academic centers, and hospitals, as well as continued proposals from Congress, is prompting industry to weigh the need for stronger self-regulation of marketing and advertising activities. PhRMA (Pharmaceutical Research and Manufacturers of America) established a voluntary DTC code of conduct two years ago, but it's fairly toothless. The code encourages FDA review of planned ads and discourages airing suggestive ads during early prime time.

But there's not much uptake on the suggestion to delay DTC advertising of newly approved drugs, and there's no enforcement mechanism or disclosure of consumer complaints. With Democrats on Capitol Hill and on the campaign trail promising to cut drug costs through tougher price negotiations, drug importing, and curbs on marketing, any pharma misstep is sure to make headlines and draw accusations of public harm and fraud.

Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at


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