Another Advocacy Group Asks FDA to Increase Marketed Unapproved Drugs Enforcement Crackdown

August 12, 2010

By Kurt R. Karst –   

The 60 Plus Association, a senior advocacy group and alternative to AARP, has joined the debate over marketed unapproved drugs, asking FDA to step-up enforcement action and starting its “Keep Seniors Safe” initiative, which “advocates the removal of unapproved drugs from the market for the safety and welfare of the public who unknowingly put themselves at risk of an adverse reaction.” 

According to a letter the association sent to FDA:

60 Plus was troubled by reports in the New York Times, Wall Street Journal, and other news sources that millions of unapproved nitroglycerine, morphine, and colchicine prescriptions were written and filled for patients across the country.  Seniors make up a substantial portion of the market for these unapproved drugs.  As such, 60 Plus is astounded by the FDA’s lack of consumer protection enforcement in the area of unapproved drugs. . . .  60 Plus urges the FDA to enhance its management of unapproved drugs and implement more stringent guidelines in mandating drug manufactures to seek FDA approval under its Unapproved Drug Initiative.

FDA kindly thanked 60 Plus for expressing its concern and detailed some of the Agency’s enforcement efforts under the Unapproved Drugs Initiative.

60 Plus joins a growing number of advocacy groups that have requested greater FDA enforcement action.  As we previously reported, the National Minority Quality Forum and MANA (a self-described national Latina organization) also sent letters to FDA asking for increased enforcement action.  And LegitScript, a self-proclaimed “leading source of information for patients, Internet users, physicians, businesses and other third parties who need to know if an Internet pharmacy is acting in accordance with the law and accepted standards of ethics and safety,” sent a letter to leading pharmacies (and FDA) noting that “[p]harmacies and distributers have the ability to change the unapproved drug market by encouraging drug manufacturers to seek FDA approval, and to refuse to fill prescriptions with unapproved drugs.”

Interest in marketed unapproved drugs has been high over the past few months.  During debate of the Patient Protection and Affordable Care Act, Senator Charles Grassley (R-IA) proposed an amendment that would have required FDA to publish a list of marketed unapproved drugs and that would have prohibited Medicaid payments for such products.  Although the amendment was not voted on, Sen. Grassley has since testified on the issue at a House of Representatives Committee on Appropriations Agriculture Subcommittee hearing, and reportedly plans to pursue legislative action at some point to further support FDA’s oversignt of marketed unapproved drugs.  More recently, FDA won a case in what appears to be the first challenge arising from the Agency’s Unapproved Drugs Initiative.  In that case, the U.S. District Court for the District of Wyoming denied a Motion for Temporary Restraining Order and Preliminary Injunction involving marketed unapproved Morphine Sulfate Solution Immediate-Release 20mg/mL products.