Arlington, Va. – In celebration of the 30th anniversary of the enactment of the Drug Price Competition and Patent Term Restoration Act, also known as the “Hatch-Waxman” Act, the National Association of Chain Drug Stores (NACDS) reflects on the evolution of providing patient access to affordable generic medications, and looks to the next 30 years in continuing this progress.
“We laud the efforts of lawmakers such as Senator Orrin Hatch (R-UT) and Rep. Henry Waxman (D-CA) for their forward-thinking leadership in opening the door to make generic drugs more affordable and accessible for patients,” said NACDS President and CEO Steven C. Anderson, IOM, CAE. “As the landscape of the healthcare system has transformed in the last 30 years, generic drugs have long-surpassed the expected impact of how they would be utilized by patients.”
When enacted in 1984, it was projected that the legislation could save Americans $1 billion. Fast-forward to 2013, the Generic Drug Savings in the U.S. report, compiled by IMS Institute for Healthcare Informatics, showed that generics saved $239 billion.
“Chain pharmacy is committed to helping patients obtain cost-effective healthcare. Looking ahead to the next 30 years, we need to continue to find ways to make prescription drugs more affordable for patients,” said Anderson.
NACDS has long-promoted policies that facilitate patient access to cost effective medications, and continues to do so in the growing area of biologic drugs: 1) patients need greater access to the generic versions of costly biologic drugs, and 2) pharmacists in all states should have the ability to substitute approved interchangeable biosimilar medications.
Biologic drugs, which can drastically improve patient health, are highly expensive medications. Under legislation enacted in 2010, a drug approval process was created so the Food and Drug Administration (FDA) can approve generic versions of biologic drugs – known as biosimilars – with the intent of providing patients with more affordable options for these types of products. NACDS continues to work with FDA to urge the agency to adopt policies that will facilitate greater access to biosimilar medications.
In addition, state generic substitution laws were enacted decades ago, well before the approval pathway for biosimilars was conceived. As such, the language in these state laws does not recognize or accommodate the substitution of interchangeable biosimilar drugs. This must be remedied so that pharmacists can substitute interchangeable biosimilar drugs consistent with existing substitution practices for other generic drugs, and continue to help patients and payors by controlling prescription drug costs and saving overall healthcare dollars.
“We look forward to working with our industry partners like the Generic Pharmaceutical Association (GPhA) and others, as well as the lawmakers and policy makers to continue building on the success of the ‘Hatch-Waxman’ Act in providing affordable access to generic medications for patients.”