Healthy Skepticism Library item: 11626

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Publication type: news

Cohen R.
Relief -- and some bitter pills
The New Jersey Star-Ledger 2007 Sep 25
http://www.nj.com/business/ledger/index.ssf?/base/business-1/1190694902193000.xml&coll=1&thispage=1

Full text:

Here’s a breakdown of how the FDA bill affects the drug industry’s big players

WASHINGTON — The House and Senate have given final approval to far-reaching legislation broadening the Food and Drug Administration’s prescription drug safety powers, providing greater disclosure of drug risks and promising the pharmaceutical industry timely reviews and approvals of new medicines.

President Bush is expected to sign the bill into law sometime this week.

The overhaul of the FDA comes three years after the popular Merck painkiller Vioxx was pulled from the market because of heart risks, and follows a number of other high-profile drug safety controversies.

The legislation received overwhelming bipartisan support in both chambers. But it was the product of nearly a year of negotiations, numerous hard-fought and last-minute compromises, and expensive lobbying efforts by drugmakers and other interests.

The health-care sector, including pharmaceutical companies and medical-device makers, spent a record $227 million lobbying Congress and the federal government during the first six months of 2007, according to the latest regulatory filings.

In the end, industry groups and patients each chalked up some wins and some losses, and in many cases split the difference to ensure passage.

Here is a look at how key interest groups fared:

BIG PHARMA

Wins:

-Secured provisions requiring the FDA to set clear timetables to review new drugs in exchange for $392.8 million in user fees for fiscal 2008, an $87.4 million increase over the current year.

-Secured provisions requiring the FDA to set clear timetables to review new drugs in exchange for $392.8 million in user fees for fiscal 2008, an $87.4 million increase over the current year.

-Fended off a plan to allow the FDA to block TV commercials for some new drugs with serious safety risks, settling for additional agency oversight.

-Retained six-month extended patent life for pediatric testing of existing medications, blocking attempt to reduce exclusive marketing rights to three months for some drugs.

-Managed to remove language that would have allowed widespread importation of lower-priced prescription drugs from abroad.

Losses:

-Failed to retain Senate language making it harder for patients to sue in state court for claims of harm from prescription drugs.

-Bowed to public and political pressure to accept new FDA authority to mandate rather than request post-market studies, labeling changes and ongoing safety reviews of some drugs.

-Accepted new mandate to disclose on public databases all clinical drug trials and their results, including adverse events.

MEDICAL-DEVICE MAKERS

Wins:

Avoided enactment of new rules to toughen pre and post-market safety oversight on such products such as heart stents, pacemakers and joint replacements.

-Obtained incentives to create medical devices designed specifically for children.

-Successfully negotiated deal to pay $287 million in user fees over five years in return for FDA commitments to review and approve new medical devices in a timely manner.

Losses:

-No significant setbacks.

GENERIC DRUGMAKERS

Wins:

-Reform of FDA citizen-petition system to reduce ability of brand-name drugmakers to use the process to delay entry of lower-cost generics to the market.

-Avoided imposition of millions of dollars in user fees for FDA review of their medications.

Losses:

-Failed to get provisions allowing for FDA approval of generic versions of expensive biologic drugs.

CONSUMER ADVOCATES

Wins:

-Secured tougher and more comprehensive post-market safety surveillance of prescription drugs by the pharmaceutical companies and the FDA.

-Locked down an extra $225 million in industry user fees over five years to help fund FDA drug safety activities.

-New limits on granting conflict-of-interest waivers to scientists and doctors sitting on FDA advisory panels over next five years.

-Mandate for drugmakers to disclose all clinical trials and results.

Losses:

-Defeated in attempt to impose tough new constraints on drugmaker advertising.

-Failed to open door to wider importation of prescription drugs in hopes of driving down costs.

-Settled for tough post-market safety and oversight plans for some drugs at discretion of FDA, rather than a mandate for the strictest oversight for all new drugs.