Beefing Up FDA Authority over Drug Supply

Yet another drug has been found to be a counterfeit; the U.S. Food and Drug Administration posted a warning recently about a counterfeit version of Adderall, the medication taken for ADHD disorder.

Since about 80% of the active ingredients in many medications are produced overseas, there’s plenty of opportunity for counterfeiting along the convoluted and diverse supply chain. Things like adulterated ingredients, substitution of ingredients, or reduced levels of active ingredients, are all too common an occurrence.

The problem of counterfeit drugs is a real and growing problem, especially when drugs are purchased online. The FDA’s efforts to deal with counterfeit drugs are hamstrung because 1) they lack authority to dispose of counterfeits in a quick and efficient way, 2) the penalties for creating or selling fake drugs are not effective enough to deter the activity, and 3) drug importers are not required to track and trace all medications throughout the manufacturing process.

The House and Senate are working on bills to resolve these issues. The House bill grants the FDA authority to require drug manufacturers to provide information about supply problems that could lead to shortages of a particular drug. Currently, this information is given voluntarily, but shortages of particular drugs, such as the cancer drug Avastin, have been in such short supply as to pose serious risk to patients.

Both bills provide for higher fees from drug manufacturers–including, for the first time, generic drug makers, to speed reviews. The fees will make up nearly half the agency’s $4.5 billion budget next year. The Senate version includes a steep increase the penalty for counterfeiting drugs, up to 20 years in prison or a $4 million fine. Recently, the House passed its version of the FDA reauthorization law to give the agency greater powers to inspect foreign manufacturing facilities or block their products if they refuse and to manage drug shortages.

But there are differences between the House and Senate versions of this bill, especially concerning the level of supply-chain tracking that will be required of the pharmaceutical industry to protect against counterfeit medications. The FDA wants a system to track small quantities from manufacturing to pharmacies; something the industry says is too expensive. The industry is backing a plan that tracks lots instead of individual containers. They say it could be refined later to track smaller quantities. The plan put up by an industry coalition would put unique serial numbers on individual drug packages, but require scanning drugs only in “lots” when they get to distributors.

Differences in both versions of the FDA reauthorization law are expected to be resolved by the end of June.