Rep. Smith: FDA's Morning-After Pill Decision Dangerous Medicine for Women and Girls
WASHINGTON, D.C. - U.S. Representative Chris Smith (R-NJ) today called the Federal Drug Administration's (FDA) decision to allow over-the-counter sales of the morning-after pill misguided and dangerous.
"The FDA was right to reject this application in 2004. Today's decision is an about face, putting the health and safety of young girls at risk. Instead of answering the questions raised by the 2004 petition, the FDA created a dual marketing scheme that puts Barr's profits over the safety of our children," said Smith.
The FDA approved an application by Barr Pharmaceuticals Inc., maker of the morning-after pill, to allow over-the-counter access to the drug for adults. A prescription will be required for sale of the drug to minors. Under this dual marketing plan the FDA is creating an entirely new type of approval that has not been authorized by Congress and has not undergone a formal rule-making process.
"The FDA has never approved the sale of any drug under this kind of dual marketing scheme before. This risky plan offers back door access to the drug by children when the FDA itself has conceded that not enough research has been done about the safety of this drug for adolescent girls. Despite claims by the FDA and Barr Pharmaceuticals that this new scheme protects children, under this approval the drug can be easily obtained and redistributed to kids," said Smith.
Because no formal rule-making process was conducted and no new legal authority for dual marketing has been authorized by Congress, this arrangement raises serious concerns about the agency's ability to ensure that this harmful drug does not get into the hands of young girls.
"Today's decision by the FDA is misguided to say the least. Approving the sale of a controversial drug under this strange arrangement, without Congressional input, and without clear guidelines for enforcement sets a dangerous precedent. In essence, the FDA has fashioned new complicated and unclear standards for prescription drug approval based on one individual drug application," said Smith.