Regulatory Focus™ > News Articles > As Compounding and Supply Chain Legislation Stalls out, Groups Urge Passage

As Compounding and Supply Chain Legislation Stalls out, Groups Urge Passage

Posted 24 October 2013 | By Alexander Gaffney, RAC

The US political system has seen no shortage of absurdity and crisis in the last few months, encompassing a shutdown of the majority of the federal government, a debt crisis, troubles with the rollout of President Barack Obama's healthcare insurance exchanges, and more. Accordingly, there hasn't been a whole lot of attention paid to other, still-pressing issues affecting the regulated healthcare products space.

Two of those issues: Pharmaceutical compounding and the safety of the pharmaceutical supply chain, both of which are the focus of legislation in the House and Senate known as the Drug Quality and Security Act (DQSA).

Background

The legislation was prompted by two issues. The first and perhaps most serious problem has been the lack of a uniform "track and trace" system for pharmaceutical products. While California has moved to implement just such a system, legislators have been interested in implementing a national standard to avoid other states introducing competing ones. The other hope, of course, is that the system will allow regulators to keep better track of the pharmaceutical supply chain, cutting down on counterfeiters and allowing them to respond more quickly to other problems as well.

The second problem, and the subject of numerous congressional hearings, has been the issue of drug compounding. Under federal law, pharmaceutical compounders are treated as separate entities from pharmaceutical manufacturers, and are allowed to operate under state-not federal-oversight. In late 2012, a massive outbreak of fungal meningitis caused by contaminated steroid injections caused legislators to re-evaluate that paradigm.

While the DQSA would take strides in addressing both issues, there's one thing it can't seem to do: get passed.

The law's track and trace provisions were famously booted out of the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012 after disagreements over its details couldn't be worked out in time. And now, with the political environment in Washington, DC closely resembling a circus, the DQSA has seen its progress stall out.

It's not the first time the measure has stalled out, either. In April 2013, pharmaceutical trade groups PhRMA and GPhA wrote an open letter to Congress in Politico calling on legislators to again take up the legislation. Shortly thereafter, legislators started doing just that, and the measure eventually saw passage in the House.

Pew Takes a Shot at Bringing DQSA Back

Now a second group is hoping that approach will work as well. On 18 October 2013, the Pew Charitable Trusts, an influential healthcare advocacy and research group, called on congressional leaders to take up the legislation in the Senate and see it through to passage.

The letter, sent to Sens. Harry Reid (D-NV), Mitch McConnell (R-KY), Tom Harkin (D-IA) and Lamar Alexander (R-TN) and Reps. Fred Upton (D-MI) and Henry Waxman (D-CA), calls the legislation a "step forward in the longstanding effort to reduce the risks of drugs made by compounding pharmacies that exceed traditional practice."

"It restores key provisions of section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and creates a 'voluntary category' of outsourcing facilities that will enable hospitals and clinics to purchase drugs made under higher quality standards," the letter explains, adding that the legislation could stand to benefit "nearly every American family.

"This bipartisan, bicameral legislation will help ensure that those drugs are safe, effective, and of the highest quality," they continued. "We urge swift passage."

A letter similar in style and substance to the one mentioned above was also sent on 24 October 2013 to Reid and McConnell, this time touting the benefits of DQSA's pharmaceutical supply chain provisions, which were called "important."

The first letter is co-signed by a prominent group of advocacy groups as well, including the American Public Health Association, Friends of Cancer Research and the Union of Concerned Scientists. The second letter was signed by Pew alone.


Letter on DQSA: Compounding

Letter on DQSA: Track and Trace


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