A discussion draft released yesterday by members of the House Energy and Commerce Committee would institute important new protections and checkpoints in the prescription drug supply and give the FDA broad new powers and resources to help ensure that unsafe or adulterated drugs don’t make it to U.S. medicine cabinets.
The sponsors—Congressmen John Dingell, Henry Waxman, Bart Stupak, and Frank Pallone—all pointed to a series of safety crises that have sickened and caused the deaths of Americans in recent years, including the heparin scare.
“We’ve learned more than a few troubling truths on the safety of some prescription medications and we’ve learned it the hard way – with tragedies,” Rep. John Dingell, a cosponsor and longtime drug safety advocate, said in a statement. “Americans have been alarmed in recent years over some very concerning issues related to the quality and safety of certain drug products. We know we need to address this, the only question now is how.”
The bill builds off of the Food and Drug Globalization Act, which was introduced in 2009, but goes further in some important ways. Here are some things it would do.
It would require industry to notify the FDA upon:
- Use of or exposure to drug which may result in illness or injury to humans or animal
- Significant loss or theft
- Reasonable probability that a drug has been or is being counterfeited
- Repeated failures by a component manufacturer to ensure compliance with quality system
- Any incident causing a drug to be mistaken for, or its labeling applied to, another drug
- Any contamination or significant chemical or physical change or deterioration after distribution, or any failure of a distributed lot to meet established specifications.
All sites making finished drugs or active pharmaceutical ingredients (APIs) would be inspected once every two-year period, unless the Secretary determines there is sufficient information to adequately assess risk, but no less frequently than four years.
The draft also puts in place new quality system requirements that include management responsibilities; the establishment of an internal and independent unit to ensure compliance with good manufacturing practices (GMP); risk management plans, and record-keeping.
The bill also includes supply chain management. Manufacturers would be required to implement procedures that ensure the “safety, identity, quality, strength, purity, and security of all drugs and other materials used by that manufacturer. The supply chain procedures shall address the entire supply chain from original source materials used in the manufacture of the drug to the manufacturer.”
If a manufacturer refuses inspection or breaches these good manufacturing practices, the law deems the drugs made under these conditions to be adulterated. The draft also establishes civil penalties for failure at $50,000 per violation per day.
Importantly, the bill also gives the FDA power to order drug recalls and to subpoena information, authorities that the agency has acknowledged in the past would allow it to do its job better. The bill would set registration fees for manufacturers (not yet specified) to help support enactment of the provisions.
This draft represents the second drug safety bill to be brought in Congress in two months. In August, the Senate introduced the Drug Safety and Accountability Act, which would increase oversight of suppliers and give FDA greater authorities, including drug recall.
For more on drug safety, visit the Pew Prescription Project’s Securing a Safe Drug Supply.
--Kate Petersen, PostScript blogger