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Reacting to reports of deaths, injuries and continuing law suits due to prescription drugs, Rep. Rosa DeLauro, D-Conn., is calling for major improvements to the drug review system at the Food and Drug Administration.

Congresswoman Rosa DeLauro, D-Conn, plans to use her clout as chairwoman of the House appropriations panel responsible for FDA funding, to improve drug safety — and it’s about time someone took the situation seriously.

Calling top agency officials simply “incompetent” over the recent crisis involving the blood-thinner drug heparin in which at least 19 people have died, DeLauro said real change can occur only with a new administration.

DeLauro was quoted in the media saying the FDA “is an agency that is charged with safeguarding the public health, but it’s being run like the keystone cops.”

In the heparin crisis, caused by contaminated ingredients from a Chinese factory, the FDA became aware of the problem only after hundreds were sickened and deaths had occurred. Of course, Congress announced an investigation.

This whole affair shows how little has changed at the agency in nearly a decade. In 1999, a contaminated antibiotic manufactured in China killed at least 17 people before the FDA took notice, and, as usual, Congress investigated. Ho-hum.

Mark Senak, commenting in a recent blog on the terrible first quarter the FDA is having, included DeLauro’s “Keystone cops” quote as one of the indications of trouble at the agency — a heavily funded, understaffed and apparently under-talented federal agency who’s single mandate is to protect the health of Americans, a job it is failing to do effectively enough.

The FDA has itself admitted it violated policy by failing to inspect the plant in China. But according to a New York Times report, drugs imported from China have soared since the last China drug scandal, while the FDA’s inspections of overseas drug plants have dropped significantly. Of the 566 plants in China that export drugs to the US, the agency inspected only 13 of them last year. The story is the same in India and other countries that make drugs or drug components for Big Pharma.

Last week Congress called on the FDA to move faster in forcing drug companies to include in their “direct-to-consumer” advertisements that flood TV every night ways for consumers to report drug side effects to the FDA. The agency tracks so-called “adverse drug events” — meaning drug side effects — and uses reports from doctors and patients to address safety problems with drugs already on the market. But because the system is voluntary, agency scientists complain, it misses the vast majority of drug reactions that occur.

“When only a fraction of adverse drug reactions are reported to the FDA, that means the system is failing,” DeLauro said. She stated her priorities are: Improving the FDA’s handling of post-market drug safety reviews; direct-to-consumer advertising; sufficient funding for generic drug reviews; addressing the agency’s advisory committee conflict of interest policies; improving device oversight; handling drug importation; and renewal of agency user fees.

Let’s keep our fingers crossed that DeLauro and company remain in place through and after this November’s election.

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