Senate to Pass Bill to Track Prescription Drugs, Expand FDA's Reach
A bill that would let the federal government track prescription drugs in their route from manufacturers to retail pharmacies is under consideration by the Senate.
The bill, which was passed by the House two months ago, would also let the federal government monitor pharmacies that compound medicines and ship them in bulk.
The bill is expected to pass the Senate easily, and Barack Obama is also expected to give his approval.
One powerful catalyst for the bill was the debacle last year in which a fungal meningitis outbreak that originated in a pharmacy called the New England Compounding Center (NECC), killed 64 people, and made another 750 ill in the United States. The Massachusetts facility was discovered to have mold and standing water amid other unsterile conditions.
Although pharmacies are regulated by state boards, medicines are typically regulated by the FDA. Because of the gap between the two, the NECC and similar pharmacies were able to evade the regulations set by the state and FDA.
Once the bill passes, pharmacies that limit their compounding to small amounts of medications in order to fill doctors’ prescriptions will still be regulated by the state. Pharmacies producing large batches of compounding that are not dependent on doctors’ prescriptions could offer to have the FDA monitor their products the same way the FDA monitors manufacturers, although they would not be required to do so.
The FDA has problems with the bill because it wants to require large-scale compounders to allow themselves to be monitored, and safety advocates also oppose the bill for its lack of compulsion. Strangely, they are joined in their opposition by the compounding industry's chief lobbying group, which is against the bill because it adds pharmacy regulations.
However, the Senate likes the bill because of its track-and-trace system, which enables the government to catch the transfer of counterfeit or stolen drugs. Drug makers would have to put serial numbers on their drug containers within four years, and ten years after the bill’s passage, the drug industry would be required to use electronic tracking codes.