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companies to distribute information contradicting risk information in drug labels, as proposed by the FDA in the draft guidance, is unacceptable.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.

1-25 of 18110 signatures
Number Date Name
18110 1 week ago erin yarrobino
18109 1 year ago John Cavener, Ph.D
18108 3.2 years ago Chris Patton
18107 3.2 years ago Michael Adler
18106 3.2 years ago Wayne DeBlaker
18105 3.2 years ago Kimberly Wiley
18104 3.2 years ago Collette Wynn
18103 3.2 years ago Stacey Feeley
18102 3.2 years ago Margaret and Thomas Greene
18101 3.2 years ago Joyce Bubello
18100 3.2 years ago Jill Lukens
18099 3.2 years ago Michelle Hughes
18098 3.2 years ago kathleen urbelis
18097 3.2 years ago Margot Boyd
18096 3.2 years ago Anonymous
18095 3.2 years ago Kevin O'Neil
18094 3.2 years ago Virginia Brown/Nolan
18093 3.2 years ago Anonymous
18092 3.2 years ago Annette Beatty
18091 3.2 years ago Lodiza Lepore
18090 3.2 years ago Norma Wilcox
18089 3.2 years ago Marla Caldwell
18088 3.2 years ago Kim witczak
18087 3.2 years ago Kim witczak
18086 3.2 years ago Stephanie Olszewski
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