Protect FDA Drug Safety Laws

Public Citizen’s Comment Urging the FDA to Keep Drug Warning Label Rules Strong

 

We, the undersigned, call on the Food and Drug Administration to withdraw its proposal to allow pharmaceutical companies to undermine FDA-approved information about pharmaceutical risks. Allowing drug salespeople to hand doctors information that makes drugs look safer than they are is potentially dangerous for patients who are subsequently prescribed these drugs. Laws and regulations requiring FDA approval of drug labels would have little meaning if a company, without prior FDA review and approval of supporting data, can distribute to physicians information about purportedly lower risks.

Instead, if new information shows that a warning in the FDA-approved drug label overstates a risk, the company should provide the evidence to the FDA, as is required under current regulations. If the FDA’s objective evaluation confirms the information, the agency can approve a label change. Allowing companies to distribute information contradicting risk information in drug labels, as proposed by the FDA in the draft guidance, is unacceptable.

Just as FDA review and approval of the warnings is wisely required when a drug first comes on the market, FDA review and approval should be maintained before a company can change — orally or on the labeling — approved warnings and other descriptions of risk information.

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