What: All Issues : Making Government Work for Everyone, Not Just the Rich or Powerful : Consumer Protection : S 1082 (Food and Drug Administration overhaul) Amendment by Grassley of Iowa on increasing fines for drug makers that violate FDA regulations/On agreeing to the amendment
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S 1082 (Food and Drug Administration overhaul) Amendment by Grassley of Iowa on increasing fines for drug makers that violate FDA regulations/On agreeing to the amendment
senate Roll Call 155     May 09, 2007
Y = Conservative
N = Progressive
Winning Side:
Progressive

This vote was on an amendment by Chuck Grassley, R-Iowa, that would increase to $2 million the maximum civil penalty for a pharmaceutical company that fails to heed certain safety measures ordered by the Food and Drug Administration (such as changes to drug warning labels).

Grassley, a long-time critic of the FDA who believes the agency is too beholden to the pharmaceutical industry, said pharmaceutical companies often flaunt FDA regulations, and that the penalties in the underlying bill would not do enough to deter them. "The penalties amount to the cost of doing business. This amendment is intended, then, to give the Food and Drug Administration, the watchdog, some bite along with its bark," Grassley said.

The amendment was offered to a bill that would overhaul the FDA's drug approval program. This program essentially allows pharmaceutical companies to pay the FDA to review and possibly approve their new drugs, if they are found to be safe.

Mike Enzi, R-Wyo., who sponsored the bill along with Massachusetts Democrat Ted Kennedy, said the civil penalties set in the underlying bill were "carefully crafted" to match existing FDA policies for other regulated products. Enzi said the bill would establish civil penalties for this area of food and drugs for the first time.

"It was no small feat to get a consensus position so that we could have civil penalties in the bill, and I think that is necessary," Enzi said. "Furthermore, I believe the very threat of a civil penalty is sufficient to deter bad behavior. This is the name-and-shame principle. The fine may be affordable to the company, but the loss of reputation is not."

The Senate voted, 64-30, to adopt the amendment. The majority of Democrats voted in favor of the amendment, though four did not (including Kennedy, one of the bill's sponsors). Republicans were split, with 18 voting for the amendment, and 26 voting against it. Thus, the amendment was adopted, strengthening the underlying bill's civil penalties for drug companies that disobey certain FDA regulations.

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