Price spikes for critical generic drugs continue to
jeopardize patient access to healthcare.
Healthcare group purchasing
organizations (GPOs) are the sourcing and purchasing partners to America’s
hospitals, nursing homes, surgery centers and clinics, and we advocate for
policy solutions to help curb generic drug price spikes affecting healthcare
providers and the patients they serve.
Supply Chain Association (HSCA) President and CEO, Todd Ebert R.Ph., recently
detailed some of the policy solutions that HSCA and its members support in a Morning
Consult op-ed, including: 1) Support for the
bipartisan “Increasing Competition in
Pharmaceuticals Act” (S. 2615), which mandates FDA priority review of
abbreviated new drug applications (ANDAs) for products with only one
manufacturer; 2) Expanded priority review for generic injectable drugs with two
or fewer manufacturers; and 3) Priority review of an ANDA in instances where
there have already been significant spikes — specifically, where the market
price of an existing product increases at a rate of more than five times the
percent change that occurred in the Prescription Drugs Index of the Consumer
Price Index for the previous year.
Governmental agencies, medical
journals and leading medical researchers have recently released new research
and reports on pharmaceutical pricing and the positive impact of competition on
the pharmaceutical marketplace.
A wrap-up of some of the relevant
reports is highlighted below:
1)The U.S. Government Accountability Office
(GAO) released an August report titled Generic Drugs Under Medicare:
Part D Generic Drug Prices Declined Overall, but Some Had Extraordinary Price
Increases, which found that significant
price spikes for some generic drugs jeopardize patient access to affordable
healthcare and drive up costs for patients, providers, Medicare and American
taxpayers. The report affirmed what GPOs hear both from healthcare provider
members and from generic drug manufacturers: Competition in the generic drug
market is critical to mitigating price spikes; a broad range of factors,
including access to active ingredients, production complexity, and supplier consolidation
affect competition; and a reduction in the FDA backlog of ANDAs could increase
competition in the market.
Manufacturing and quality control problems that disrupt
supply are the primary cause of drug shortages;
Increased competition from suppliers is part of the
solution to persistent shortages; and
FDA priority review of applications for sterile injectable
drugs has been effective in helping to address some shortages.
of the American Medical Association (JAMA) published a review in
July conducted by Harvard Medical School Researchers on prescription drug cost
drivers in the United States titled, The High Cost
of Prescription Drugs in the United States: Origins and Prospects for Reform. The study authors found that the FDA’s backlog of ANDAs
has, in some instances, led to delays of up to three or four years for product
review and approval, which discourages manufacturers from trying to bring
competitive products to market.
HSCA and its member GPOs
consistently advocate for policy solutions that reduce costs, increase
competition, and remove barriers to market entry. Common-sense policy solutions
such as these will help foster competition, speed up entry for new
manufacturers and help avoid generic drug price spikes in the future.