Burden of proof of safety must fall on drug manufacturers: Woodcock

Validation Times, May, 2008 by Joseph Pickett

Top FDA officials broke ranks with the Bush administration at a recent hearing of a House Energy and Commerce subcommittee, saying they would welcome Congress to grant it powers to order recalls of drug products, require foreign firms to divulge data in inspections and block suspicious imports from gaining access into the U.S.

The hearing of the Oversight and Investigations Subcommittee April 29 focused on imported active pharmaceutical ingredients (API) from overseas, especially China and the recent heparin contamination, which claimed the lives of more than 700 patients worldwide.

Panel Chairman Bart Stupak (DMI) asked FDAers: "Right now we [FDA] must show at the border that the API is unsafe. The burden is on us. Wouldn't it be better if the firm has the obligation to prove it?"

CDER Director Janet Woodcock, M.D., said FDA currently has the burden of proof to show the appearance of a violation in order for shipments of drugs to be stopped at the U.S. border.

"If it were incumbent upon a manufacturer to show they meet FDA requirements, that would make a much better and safer drug supply. We can't keep a drug out just because we have not been on that site to inspect," she said.

She added: "We need a safety net that includes more audits, better protection at the border, and we need st possible science and the IT systems to support these efforts."

Deborah Autor, CDER's director of compliance, said that while the burden-on-FDA standard did not appear to delay voluntary recalls of lots of heparin in the U.S., "resistance from manufacturers to recall in the past has happened because we lacked the authority to order it."

To have a more proactive drug safety import system, for products, have good distribution/import practices, and more tests for impurities. be possible to anticipate all types of thuggery, but we can put a plan into place where we are looking for it."

Autor noted that it is not a violation of the law to send inspection. "We cannot requ recall, we can only ask for one" under current law, she said, adding it wou be helpful for Congress to give FDA such powers.

But Stupak snapped at Woodcock and Autor, asking: "How do you work with Congress if you don't ask for authority?"

"We are providing this testimony for this purpose," Autor replied. Stupak criticized the Bush Administration for never asking formally to give the agency the power to recall drugs as it has to mandate recalls of medical devices.

By Joseph Pickett, Managing Editor