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ARLINGTON, Va. — The strong relationship between retail pharmacy and the generic drug industry was stressed by the National Association of Chain Drug Stores as it marked the 30th anniversary of the enactment of the Drug Price Competition and Patent Term Restoration Act, also known as the Hatch-Waxman Act.
Since the law’s inception, generics have grown to dominate the market. In 2013, 86% of drugs dispensed were generics, compared with 18% before the 1984 legislation. NACDS reflected on the evolution of patient access to affordable generic drugs and said it looks to continue that progress.
“We laud the efforts of lawmakers such as Sen. Orrin Hatch [R., Utah] and Rep. Henry Waxman [D., Calif.] for their forward-thinking leadership in opening the door to make generic drugs more affordable and accessible for patients,” NACDS president and chief executive officer Steve Anderson commented. “As the landscape of the health care system has transformed in the last 30 years, generic drugs have long surpassed the expected impact of how they would be utilized by patients.
“Looking ahead to the next 30 years, we need to continue to find ways to make prescription drugs more affordable for patients,” Anderson added.
NACDS noted that it has long-promoted policies that facilitate patient access to cost-effective medications, and it continues to do so in the growing area of biologic drugs. The association takes the position that patients need greater access to the generic versions of costly biologic drugs — known as biosimilars — and phamacists in all states should have the ability to substitute approved interchangeable biosimilar medications.
Under legislation enacted in 2010, a drug approval process was created so the Food and Drug Administration can approve generic versions of biologics, with the intent of providing patients with more affordable options for these types of products. NACDS said that it continues to work with the FDA to foster the adoption of policies that will promote access to biosimilar medications.
In addition, NACDS pointed out, state generic substitution laws were enacted decades ago — well before the approval pathway for biosimilars was conceived — and the language in state laws does not recognize or accommodate the substitution of interchangeable biosimilars.
The association said this situation must be remedied so that pharmacists can substitute interchangeable biosimilars consistent with current substitution practices for other generics, in turn helping patients and payers control prescription drug costs.
