Unapproved drugs: The myths and the facts

MYTH: Only FDA approved drugs are prescribed and sold in the United States.            

FACT: In the FDA’s Marketed Unapproved Drugs—Compliance Policy Guide, the FDA estimated that there are “up to several thousand” unapproved drugs available in the United States today.  Making matters worse, many doctors are unaware that unapproved drugs are readily available in the marketplace and prescribe them to patients under the assumption that they are FDA approved. A recent New York Times article reported that millions of prescriptions for unapproved nitroglycerine products were written by doctors last year and that many of those doctors didn’t know that the prescriptions were for unapproved products. Upon learning that they had been prescribing untested pills, the doctors said that they had no “way of knowing whether patients have suffered unnecessarily as a result.”

F.D.A. Says Millions Got Unapproved Nitroglycerin – New York Times 

MYTH: Generic drugs and unapproved drugs are one and the same.

FACT: Unlike unapproved drugs, generic drugs must meet strict FDA guidelines.  Unapproved drugs have never been subjected to the FDA approval process that ensures the safety and efficacy of drugs sold on the marketplace.  As one FDA official stated in the agency’s Single-Ingredient Oral Colchicine Video, unapproved drugs “may have been manufactured under substandard conditions, may contain too much, or too little, if any active ingredient and may not have the necessary labeling information and warnings.”

FDA.gov

MYTH: Due to the short period of market exclusivity awarded by the FDA to manufacturers who are first to gain approval for a certain type of drug, the price for that drug inevitably raises and becomes too expensive for most patients to purchase.

FACT: The period of market exclusivity, which is necessary to incentivize companies to come forward and put their drug through FDA’s approval process, does often result in an increase in price for a medication, however many manufacturers offer generous patient assistance programs to help patients who can’t afford their medications. More importantly, the rigorous FDA approval process helps protect consumers from the potential risks posed by unapproved drug use, which can result in harmful side effects—in some cases, death.

 MYTH: Unapproved drugs are legal because they have been “grandfathered” into the market.

FACT: According to its Marketed Unapproved Drugs—Compliance Policy Guide, to be considered a grandfathered drug, a product’s composition and labeling must not have changed in any way since 1962.

The FDA, however, “believes it is not likely that any currently marketed prescription drug product is grandfathered or is otherwise not a new drug” according to these standards.

MYTH: The FDA has done all it can do to protect the American people from the possible dangers of unapproved drugs.

FACT: The FDA announced its Unapproved Drugs Initiative in 2006, which called for the removal of unapproved drugs from the marketplace. Four years later, thousands of different unapproved drugs still remain. Though the agency has recently sent warning letters to manufacturers of unapproved nitroglycerine, morphine and colchicine products, most manufacturers have never received warning letters. The FDA must step up its efforts to protect patients from the potential harms of unapproved drugs by cracking down on all manufacturers of unproven products, especially when FDA approved versions are available.