Biopharmaceutical Research and Manufacturing Sector on U.S. Court of Appeals Oral Arguments Against Alameda Ordinance
Published Online: Friday, July 11, 2014
WASHINGTON, D.C. (July 11, 2014) Today, counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA), joined by the Biotechnology Industry Organization (BIO) and the Generic Pharmaceutical Association (GPhA), participated in oral arguments in the U.S. Court of Appeals for the Ninth Circuit, in appeal of the district court ruling in favor of Alameda County's Safe Drug Disposal ordinance, which requires pharmaceutical companies to bear the full burden of designing, funding, and operating a collection program in the county for unused medicines in the home.
"Today's oral arguments offered an important opportunity to educate stakeholders within Alameda County and all of California about the unnecessary and burdensome impacts that will result if this proposed take back program is allowed to stand. This proposed approach is impractical, inefficient and reflects an attempt on the part of the county to directly, significantly, and unconstitutionally regulate companies whose connection with Alameda is nothing more than having introduced federally-approved products into interstate commerce.
We support safe disposal of medications, and today consumers have several options available to them that are considered safe and effective by both the FDA and DEA. These methods include various means of convenient in-home disposal, as well as take back days organized by local and national law enforcement agencies, among others.
While existing programs like the DEA National Take-Back Day can offer benefits to communities, creating mandates for dispersed take-back sites that place funding and sole responsibility upon the manufacturers of medicine is not only unfair cost-shifting, but may well increase the risks associated with unused medicines. We remain confident in our legal position, and look forward to continued collaboration with local leadership to address patient safety and disposal concerns."
GPhA applauds the new findings of the Senate Special Committee on Aging and welcomes further conversation on increasing generic drug utilization in government programs, particularly Medicare Part D.
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.