NACDS reflects, looks ahead on 30th anniversary of 'Hatch-Waxman' Act

GPhA says 'generic industry’s future could not be brighter'

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 issued a statement to reflect on the evolution of providing patient access to generic medications and noted that it is looking forward to further progress in the years ahead.

“We laud the efforts of lawmakers such as Senator 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,” stated NACDS president and CEO Steve Anderson.  “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,” Anderson stated.

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.

NACDS noted that 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 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 stated that it continues to work with the 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. According to NACDS, 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 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,” Anderson stated.

In commenting on the anniversary of the “Hatch-Waxman” Act, GPhA president and CEO, Ralph G. Neas, stated, “Today, the generic industry’s future could not be brighter. The Hatch-Waxman law created a strong foundation for a dynamic and evolving generic drug industry, and with emerging opportunities from a global marketplace, expanded health coverage access, and the needs of an aging population, the industry has never been stronger. As we look forward to the next frontier of affordable medicines, biosimilars, a recent study by Express Scripts estimates that hundreds of billions of dollars in savings are at stake. Over 10 years, the report showed, the United States would save $250 billion if just the 11 likeliest biosimilars would enter the market.”

Neas added, “We must embrace the spirit of the Hatch-Waxman law and build on its remarkable achievements. It is essential to recognize that balancing competition with access to affordable medicines can revolutionize the market, offer consumers quality and safe choices, and inspire innovation. ”

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