FDA: Drugmakers responsible for safety

Congress may be all fired up about funding more foreign inspections by the FDA, but the agency itself? Not so much. In multiple appearances before congressional committees, Commissioner Andy von Eschenbach pointedly declined to seek more money for foreign inspections. CDER chief Janet Woodcock went so far as to tell a Senate panel last week that drugmakers need to take responsibility for the quality of their own products.

Increased funding for inspections is all well and good, Woodcock said, but the agency needs better IT systems to track manufacturers and imports, too. And no matter what, the huge volume of pharma ingredients and products made overseas makes it close to impossible to ensure the safety of all drugs sold in the U.S. The FDA can never be "the quality-control unit for the world," she said.

Sounds a lot like the push-back from China early in the heparin scandal, when regulators there said importers needed to bear the responsibility for drug safety. But while China seemed to be simply shoving aside blame, Woodcock is saying that enforcement can't do everything. If drugmakers aren't serious about the quality of their own products from the beginning of their supply chains to the pharmacy shelves, then problem products will get to patients. "We're holding them accountable for their quality system, not being their quality system," she told reporters after her testimony. Maybe what FDA needs as much as new funding is some real power to punish errant manufacturers. Otherwise, this "holding accountable" is nothing more than window-dressing.

- see the story in Pharma Times
- check out the Pharmalot item
- read the Wall Street Journal article on funding
- get the New York Times editorial

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