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Regulatory Focus™ > News Articles > Waxman, Author of Legislation Creating Generic Drug Industry, Orphan Drug Provisions, to Retire

Waxman, Author of Legislation Creating Generic Drug Industry, Orphan Drug Provisions, to Retire

Posted 30 January 2014 | By Alexander Gaffney, RAC

Representative Henry Waxman (D-CA), a Democratic legislator who has been a fixture in Congress and a major influence in legislation shaping the US Food and Drug Administration (FDA) since 1975, has announced that he will retire at the end of his current term.

Waxman, 74, served on and once chaired the Energy and Commerce Committee, which has jurisdiction over FDA in the House of Representatives.

The legislator may be best known for his role in creating the generic drug industry through the passage of Drug Price Competition and Patent Term Restoration Act in 1984, more commonly known as the Hatch-Waxman Amendments.

In a statement announcing his pending retirement, Waxman said he was especially proud of his role in creating the generics industry.

"I took on the pharmaceutical companies that did not want competition and joined with Senator Orrin Hatch to write the law that created the generic drug industry, saving families over $1 trillion in the last decade alone," he wrote.

Waxman was also the chief sponsor of the Orphan Drug Act, which created a regulatory framework for approving drugs for rare and orphan diseases. That legislation has already "led to treatments for hundreds of rare diseases," he said.

In recent years, Waxman's influence has waned somewhat, as Republicans re-took the House. He was nevertheless a constant fixture in advocating for changes at FDA, introducing legislation to require FDA to collect antibiotic prescribing data and for the industry to be barred from participating in "pay-for-delay" agreements.

Tags: House, Congress

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