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Pharmaceutical Executive Explains Decision to File Lawsuit Against FDA

April 24, 2019

Ed Thompson, president of Pharmaceutical Manufacturing Research Services, made headlines in December when he filed a lawsuit against the U.S. Food and Drug Administration to force it to limit the availability of his company’s new opioid medication to short-term use.

It’s a risk to PMRS’s bottom line—one that landed him on “60 Minutes”—but it was a step that he told attendees of the Rx Drug Abuse & Heroin Summit was necessary.

“It was not our best recourse,” he said during the morning plenary session on Tuesday in Atlanta. “It was our only and last recourse available.”

Thompson’s gambit was launched in hopes of steering the FDA into requiring substantial scientific evidence of efficacy for the intended use of new drugs. The practice was established in the Kefauver-Harris amendments to the Federal Food, Drug and Cosmetic Act in 1962, but it is a standard not being recognized by FDA.

Having the freedom to label drugs as effective for daily, around-the-clock, long-term treatment makes them more marketable—and more profitable—for pharmaceutical companies. Thompson’s lawsuit could bring $7 billion to $10 billion off the market, he said in his interview with “60 Minutes.”

Still, he explained to Rx Summit attendees, it is a move that many of his peers in the industry were on board with.

“If the pharmaceutical industry, including companies not involved with opioids, don’t clean their own house, they will never be successful,” Thompson said. “You can’t run a business with a declining life expectancy when your business is to extend life expectancy.”

Opioid epidemic’s workforce impact

During a Congressional update session on Tuesday at the Rx Summit, U.S. Rep. Earl “Buddy” Carter (R-GA) shed light on the impact the opioid epidemic has had on the nation’s workforce. Among the findings he shared:

  • 919,400 prime-age individuals were not in the labor force in 2015 due to opioids
  • 12.1 billion cumulative work hours of labor force participation were lost, costing $702.1 billion in real output

Carter acknowledged that even having practiced pharmacy for more than 30 years, “I don’t think even I saw the problem that was arriving there.”

Carter then discussed various bills related to tackling the opioid epidemic that he has sponsored which are currently working their way through Congress, including:

  • H.R. 5483, which would direct the U.S. attorney general to issue a special registration to healthcare providers to provide controlled substances via telemedicine
  • H.R. 4275, which would help pharmacists detect fraudulent prescriptions
  • H.R. 5582, which would require the Centers for Medicare & Medicaid Services to examine the barriers to accessing abuse-deterrent opioid formulations for individuals enrolled in Medicare Part C or Part D
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