US legislators have announced that they have overcome differences in their approaches to reforming the regulation of compounding pharmacies and the pharmaceutical supply chain, clearing a path for potential approval.
As regular readers of Regulatory Focus know, legislation to reform pharmaceutical compounding and track and trace has been in the works for months.
In general, the House of Representatives and Senate have taken different approaches toward reforming the sectors. In the Senate, legislators had opted to combine both pieces of legislation into a single entity. The House, meanwhile, had chosen to take up the legislation separately, reflecting members' significant concerns over the compounding legislation and whether FDA needed additional authority over the sector.
For a primer on these issues and previous iterations of the legislation, please see the following Focus articles:
Legislators Breach Impasse
Now legislators have announced that they have reached a compromise over their approaches, reflected in a combined piece of legislation known as the Drug Quality and Security Act (DQSA) of 2013.
The 146-page legislation is notably lengthier than previous iterations of the legislation, reflecting numerous changes and two distinct titles: One on drug compounding and the other on track and trace.
As was expected, the legislation marks a shift from the Senate's approach toward compounding in favor of the House's approach, which had received bipartisan legislative support as well as general support from the pharmaceutical compounding industry.
In particular, the DQSA will include a regulatory carve-out for outsourcing facilities that meet defined conditions intended to preserve the ability of small-scale hospital compounders to avoid expensive and potentially onerous regulatory requirements and other manufacturers to ease drug shortages.
Large-scale and bulk compounders, however, would be subject to newly clarified regulation by the US Food and Drug Administration (FDA), and the legislation maintains a provision that prohibits the compounding of drugs that are "essentially a copy of a marketed and approved drug." This provision in particular could be welcomed by a number of traditional pharmaceutical manufacturers which have seen their product launches crippled by compounded competition, such as KV Pharmaceutical's Makena.
Other notable requirements:
- FDA has the explicit authority to inspect manufacturing sites that compound, in accordance with a "risk-based schedule."
- Compounders will have to report adverse events to FDA.
- A user fee structure will be put into place to fund new FDA inspections and inspectors.
- State regulators and FDA will be required to communicate more closely with one another.
- The Government Accountability Office (GAO) will need to generate a report on pharmaceutical compounding within three years of the act's passage.
"Plain and simple, this legislation will help ensure that providers and their patients have access to high-quality compounded drugs," said Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Tom Harkin (D-IA). "This legislation will improve the safety of compounded drugs by clarifying the oversight responsibilities of the FDA over large-volume compounders and by holding facilities to high quality standards."
Track and Trace
But if the DQSA reflected the House approach on compounding, it borrows most heavily from the Senate's approach on track and trace measures.
The section, entitled the "Drug Supply Chain Security Act," calls for all drug packages to carry a serial number within four years-not five, as some previous versions had called for. In addition, the legislation would implement a lot-level tracking system four years after the law's passage, with a package-level tracing system (also known as unit-level) coming into effect 10 years after.
Most other parts of the legislation-nearly 100 pages in all, including almost a dozen on just the definition of various terms-closely mirror earlier iterations of the Drug Supply Chain Security Act.
Also of note:
- Within one year, FDA will have to issue guidance on meeting track and trace regulations.
- Within two years, FDA will have to establish a waiver process for becoming exempt from regulations.
- By 1 January 2015, companies will have to have systems in place to allow FDA to investigate (and if necessary, quarantine) products it believes to be compromised.
- The legislation would pre-empt California's state track and trace measures.
With the support of influential committee leaders from both houses of Congress, passage of the legislation seems increasingly likely. The bill does seem to have attracted more Democratic supporters than Republicans ones, meaning the biggest hurdle to its passage may still be the Republican-controlled House of Representatives.
DQSA Draft (via RxTrace)