Hatch-Waxman Act: 25 years in the making


ARLINGTON, Va. On Sept. 24, 1984, president Ronald Reagan signed into law a bill that spawned an industry.

The Drug Price Competition and Patent Term Restoration Act, also known as the Hatch-Waxman Act, created an abbreviated pathway for the Food and Drug Administration to approve generic pharmaceutical drugs.

According to the Generic Pharmaceutical Association, which had its Annual Policy Conference in Washington last week, attended by bill sponsors Rep. Henry Waxman, D-Calif., and Sen. Orrin Hatch, R-Utah, generic drugs account for more than 70% of prescriptions dispensed, but 17% of the money spent.

“Twenty-five years ago, I’m not sure president Reagan, Sen. Hatch or Rep. Waxman could have truly envisioned the extraordinary success and lasting magnitude of the Hatch-Waxman Act,” GPhA president and CEO Kathleen Jaeger said in a statement. “Our industry is proud of how far it has come in the past 25 years.”

Sen. Hatch echoed the sentiment.

“Henry and I put our differences aside to work in a bipartisan manner to get that bill passed,” Hatch said in a speech at the GPhA conference. “There were provisions in that bill that I opposed, and there were provisions that Henry opposed. But in the end, we passed a bill that has not only worked well, but has saved consumers, state and federal governments billions of dollars.”

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