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Unapproved Medicines Have A New Foe: The FDA’s Renewed Focus

A recent Washington Post article indicates that the FDA is taking fresh and welcomed steps to tackle the ongoing problem of unapproved drugs on the consumer market.

The article indicates that the Food and Drug Administration (specifically, FDA drug compliance Director Deborah Autor) is leading an initiative to rid the market of potentially dangerous unapproved medications. Ms. Autor will be confronting the challenges posed by unapproved drugs with a comprehensive plan that evaluates the public health risks, examines legal issues and identifies incentives to get drugs approved. The plan also helps seeks to educate the public and aggressively promote the role of enforcement.

In the Post article, the FDA’s Director of the Center for Drug Evaluation and Research (CDER) had praise for Ms. Autor, crediting her with “persistence and laser like focus to this goal, and conceived and executed strategy. In doing so she improved drug safety for the American people.” Similarly, Steven Galson, a former U.S. Surgeon General and FDA official, said that she “developed the program under budget constraints, withstood scrutiny and criticism from some in the drug industry and Congress, successfully navigated the internal FDA process and took aggressive action to clamp down on the illegal drug market.”

It’s important to understand the central and important role that the FDA plays in protecting the public health from unapproved drugs – medicines that have not been subject to the FDA’s rigorous drug approval process, and accordingly, have not been confirmed to meet the FDA’s drug safety and efficacy requirements. LegitScript recently urged leading pharmacies to be aware of this issue, and has encouraged the FDA to refocus on the unapproved drug issue.

Unapproved drugs can take a variety of forms. LegitScript’s primary focus has been unapproved drugs via “rogue” or “unapproved” Internet pharmacies. (Prescription drugs imported directly from outside of the US directly to the patient are, in almost all cases, considered unapproved by the FDA.) However, there are also numerous prescription drugs that may be sourced domestically but have not been verified as meeting the FDA’s safety and efficacy requirements. Indeed, one of Autor’s findings was that many of the drugs predating the approval process or “grandfathered” drugs have been altered in their dosage, formulation and administration and therefore would no longer appropriately be “grandfathered” under federal drug safety laws, and cannot be verified as safe and effective.

We’ve typically described such unapproved drugs as a “gamble”: in some cases, the patient will get something safe and effective, but in others, they do not. LegitScript welcomes the FDA’s updated focus on unapproved drugs, and notes that both pharmacies and patients will benefit from continuing education as to which drugs are considered unapproved.