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companies to distribute information contradicting risk information in drug labels, as proposed by the FDA in the draft guidance, is unacceptable.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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Number Date Name
18107 1 year ago Christopher Patton
18106 1 year ago Michael Adler
18105 1 year ago Wayne DeBlaker
18104 1 year ago Kimberly Wiley
18103 1 year ago collette Wynn
18102 1 year ago Stacey Feeley
18101 1 year ago Margaret and Thomas Greene
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18088 1 year ago Norma Wilcox
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18086 1 year ago Kim witczak
18085 1 year ago Kim witczak
18084 1 year ago Stephanie Olszewski
18083 1 year ago Cynthia McGrane
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