Letter

Congressional Panels Announce Bipartisan, Bicameral Bill to Enhance Patient Safety

On Sept. 25, two congressional panels announced a bipartisan, bicameral bill that would establish a national system to track and authenticate U.S. medicine and enhanced federal oversight of pharmaceutical compounding.

In response, Pew sent a letter to leadership in the Senate Committee on Health, Education, Labor, and Pensions and House Energy and Commerce Committee, supporting the legislation as a step forward in patient safety.

Download the letter (PDF)


September 26, 2013

 

The Honorable Tom Harkin
Chairman
Committee on Health, Education, Labor and Pensions
U.S. Senate  
  The Honorable Fred Upton
Chairman Committee on Energy and Commerce
U.S. House of Representatives  
     
The Honorable Lamar Alexander
Ranking Member
Committee on Health, Education, Labor and Pensions
U.S. Senate
  The Honorable Henry Waxman
Ranking Member
Committee on Energy and Commerce
U.S. House of Representatives

 

Dear Chairman Harkin, Ranking Member Alexander, Chairman Upton, Ranking Member Waxman, 

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Thank you for your tireless work to address threats to the safety of our nation's drug supply. Although we would like to see further improvements (outlined below), the Pew Charitable Trusts supports the Drug Quality and Security Act, which
represents a major advance for the security of U.S. drug distribution and a step toward regulatory clarity and higher quality
standards for compounded medicines.

Title I - Drug Compounding

This title clarifies current federal law with respect to compounded medicines and creates a new, voluntary category of outsourcing facilities that would operate under higher quality standards and more stringent federal oversight.

By reinstating section 503A of the Food Drug and Cosmetics Act, the bill addresses FDA enforcement difficulties that have arisen from divided court rulings on this section. It creates a uniform national standard to enable the FDA to provide
oversight of compounding facilities and take action against those that produce adulterated, misbranded or unapproved new
drugs, as well as to promulgate any needed updates to guidance or regulation.

Secondly, section 503B creates an FDA oversight category that sterile compounders may voluntarily join. Because 503B is voluntary, many compounders may continue to produce large volumes of sterile products primarily under state oversight
which is highly variable. However, this will create the potential for a market for drugs produced under FDA oversight and
good manufacturing practices - the strong quality standards applied to the pharmaceutical industry.

Conversely, the voluntary nature of section 503B means that facilities voluntarily paying fees to FDA and producing drugs under higher quality standards will have to compete against those operating at lower standards. We acknowledge that Congress has instructed the Government Accountability Office to assess the outcome of this new category in three years'
time.

Both 503A and 503B maintain or establish important protections, such as prohibitions on the compounding of medicines that are “essentially a copy of a marketed drug” and the FDA ability to establish a list of products that may not be compounded for safety reasons.

Title II – Drug Supply Chain Security

This legislation has several key elements that make it a significant advance for patient safety.

First, it establishes a clear path to an electronic, interoperable unit-level traceability system in 10 years' time for pharmaceuticals distributed in the United States. Tracking and authenticating drugs at the unit level will allow the identification of stolen, diverted, or counterfeit products. The bill requires serial numbers to be placed on all drug packages in 4 years' time, and includes requirements to use the serial numbers in advance of the electronic unit-level traceability system.

Second, it establishes interim product verification and traceability standards that will be built-upon under the eventual electronic traceability system. Through guidance, FDA will specify enhanced verification and traceability standards, as well as the manner in which data can be exchanged in an interoperable fashion.

Third, it requires the participation of all sectors in the supply chain (except as noted below). Participation of all sectors in a serialization and traceability system is critical to its integrity. We support the special considerations included here to prevent economic hardship to small businesses, but we also urge Congress to use its oversight authority to ensure that modified compliance for small pharmacies should not result in gaps that allow illegitimate product to reach patients. We note that under this bill, third party logistics providers (3PLs) are subject to uniform federal licensure standards, but are not required receive or keep records on transactions, or participate in investigations. Because 3PLs of all sizes play a major role in physically storing and moving drugs, we urge you to reinstate those provisions.

Fourth, it achieves regulatory certainty by making the unit-level system a statutory requirement, rather than depending on FDA regulation to achieve this. This clear statutory requirement will create the regulatory certainty to allow supply chain stakeholders to build systems towards a specific goalpost, and make effective investments in tracking technology.

We urge Congress to remedy one important shortcoming of this legislation. In its current form, the draft fully preempts all state drug pedigree laws upon enactment, but does not replace them with a federal system for more than a year (potentially much more if implementation of the federal system slips beyond the deadline established in this legislation). This creates a long period of time during which there would be no pedigree protections in place in the United States at all. We strongly urge you to delay preemption of state pedigree laws until transaction history requirements go into effect.

Thank you again for your leadership on these important issues,

Sincerely,

Allan Coukell
Senior Director, Drug and Medical Devices
The Pew Charitable Trusts 


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