The US Senate's Health, Education, Labor and Pensions (HELP) Committee has advanced two long-sought-after proposals that would overhaul the framework by which the US Food and Drug Administration (FDA) regulates the compounding, tracking and tracing of pharmaceutical products.
Both the House and Senate are concurrently working on two sets of proposals: one to change how pharmaceutical compounders are regulated, and one to shore up the pharmaceutical supply chain.
The former comes after dozens of deaths and hundreds of injuries resulting from deficient compounding practices at a Massachusetts-based compounding pharmacy, the New England Compounding Center (NECC). Problems at that facility resulted in hundreds being infected with a rare strain of fungal meningitis. Furious legislators hauled top FDA officials before several hearings, demanding of them answers for why the agency did not stop those products from reaching market despite being made aware of general problems at the facility nearly a decade before and again in the interim years. FDA's answer: Thanks to several conflicting court cases and Congress itself, the agency lacks the statutory authority to inspect compounding facilities with the same vigor as it does traditional pharmaceutical manufacturers.
On 22 May 2013, the Senate HELP Committee unanimously passed the Pharmacy Compounding Quality and Accountability Act , which it said will help solve the problems now facing regulators by giving FDA new regulatory authority while preserving some of the structures inherent to the existing system. The passage came just as the committee released a new report illustrating some of the more egregious problems within the compounding sector, including the huge number of products being recalled by compounding pharmacies.
"The Pharmaceutical Compounding Quality and Accountability Act will clarify oversight of pharmaceutical compounding, leaving traditional pharmacies under the supervision of states, while enabling FDA to regulate compounding manufacturers, companies that make compounded sterile drugs without prescriptions, and ship them across state lines," Sen. Tom Harkin (D-IA) wrote in a statement.
The legislation contains several provisions called for by FDA and legislators alike, including:
- FDA will now have explicit authority to treat compounded products as a "new drug" under the Federal Food, Drug and Cosmetic Act (FD&C Act)
- Compounders would be banned from making copies of FDA-approved drugs
- A new category of "compounding manufacturers" would be created, while leaving traditional compounders with fewer restrictions
- Any compounder that creates sterile products would be subject to greater regulatory oversight
- Compounding pharmacies would need to register with FDA
- Compounders would need to pay user fees to FDA ($15,000 each per year) to support oversight measures such as inspections and registration
The New York Timesreports that congressional staffers say the bill will most likely be considered by the full Senate in July, after which time it would need to be either passed by the House of Representatives, or reconciled with a similar bill now being considered by the House Energy and Commerce Committee.
Track and Trace
The latter of the Senate's two proposals, the Drug Supply Chain Security Act, also known as the track and trace bill, comes after repeated instances of counterfeit products entering the US supply chain. At issue for regulators is the ability to establish a trusted pedigree for a drug, allowing them to track a drug as it moves throughout the supply chain and trace it back to its point of origin when something goes wrong. As a Wall Street Journal investigation in 2012 showed, the path of a counterfeit drug product can span several countries and continents, and it's not always clear where something comes from.
The Senate's bill looks to alter that by instituting a number of new requirements on current manufacturers and distributors. Among them:
- Lot-level tracking requirements established for drug products, with unit-level tracking in the future.
- Product identifiers will need to be affixed to a product within four years of the date of the law's enactment.
- Manufacturers may only distribute their products to authorized trading partners.
- Within one year, manufacturers will need to have systems in place to identify counterfeit products in their possession.
- National requirements established that pre-empt state laws.
- New licensing requirements are put in place for wholesalers.
- A new public database to track licensed wholesalers will be created.
- FDA will publish draft guidance on track and trace requirements.
- Regulators would have the request data from entities; information would not be kept in a real-time database.
- Transaction history is required to be kept by entities, including manufacturers, for six years after the date of the transaction.
The bill passed the HELP Committee on 22 May 2013, and now moves to the full Senate for a vote, after which time it will need to be reconciled with the House of Representatives' version of the bill before being sent to the president for likely approval.