GPhA Applauds Senate Passage of Supply Chain Safety Legislation

Published Online: Monday, November 18, 2013
Follow Pharmacy_Times:

WASHINGTON, DC, (November 18, 2013) — The Generic Pharmaceutical Association (GPhA) commends today’s Senate vote to pass the Drug Quality and Security Act (HR 3204), legislation that makes it easier to monitor drugs throughout the supply chain.

“Establishing a predictable, reliable national standard for electronic prescription medicine tracking further safeguards our nation’s prescription drug supply and protects patients,” said Ralph G. Neas, President and CEO of the Generic Pharmaceutical Association. “This bipartisan bill is the culmination of years of hard work from Congress and stakeholders at every level of the supply chain. Modernizing the nation’s prescription drug tracking system enhances the ability of regulators to limit risks posed by counterfeit or adulterated products and reassures patients that the generic medicines they receive are secure from the manufacturer all the way to the pharmacy.”

The Drug Quality and Security Act replaces a patchwork of state laws with a uniform, consistent national standard for keeping accurate records of prescription medication. The bill requires manufacturers to put serial numbers on all medication containers within the next four years. In the next decade, electronic tracking codes are expected to monitor medication at the package level from manufacturer through to the pharmacy.

In particular, GPhA applauds Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Sen. Tom Harkin (D-IA), Senate HELP Ranking Member Sen. Lamar Alexander (R-TN), Sen. Michael Bennet (D-CO), Sen. Richard Burr (R-NC), as well as House Energy and Commerce Committee Chairman Rep. Fred Upton (R-MI), House Energy and Commerce Ranking Member Rep. Henry Waxman (D-CA), Rep. Bob Latta (R-OH) and Rep. Jim Matheson (D-UT) for the years of hard work that culminated in the bipartisan passage of this legislation.

GPhA looks forward to the Drug Quality and Security Act reaching the desk of the President where it is expected to be signed into law. GPhA also supports electronic labeling provisions that remain under discussion and encourages continued efforts to finalize the proposed rule on e-labeling.
Related Articles
The Generic Pharmaceutical Association welcomes the FDA’s proposed rule to amend its prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for healthcare professionals.
The Generic Pharmaceutical Association has serious concerns about the unbalanced structure of the Trans-Pacific Partnership agreement in its current form.
GPhA has agreed to support compromise automatic substitution legislation that would allow interchangeable biologics to be automatically substituted at the pharmacy. This step brings millions of Americans closer to the day when they will be able to access safe alternatives to costly biologic medicines. Indeed, Express Scripts projects savings of $250 billion in 10 years should only the 11 likeliest biosimilars enter the market.
“GPhA applauds FDA for taking helpful steps to address, and hopefully limit, scenarios in which some brand drug companies misuse Risk Evaluation and Mitigation Strategies programs to thwart competition from more affordable generic drugs. The ongoing abuse of REMS and REMS-like programs costs the American health system and its patients $5.4 billion annually, according to a study conducted by Matrix Global Advisors. Interestingly, as the United States market readies for biosimilars, this same study identifies $140 million in lost savings that would occur for every $1 billion in biologics sales.
Latest Issues