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Rita Peters is editorial director of Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International.
Faced with divisive political and social issues, Congress must find a way to reach consensus.
The summer of 2017 was a busy one for US citizens and companies. It seemed that every week a new crisis or revelation would push equally pressing issues from the front page. The past few months saw an ongoing investigation into alleged Russian meddling in the 2016 election, staff turnover at the White House, violence driven by racial divisions, a nuclear threat from North Korea, and the devastation to lives, homes, businesses and infrastructure in Texas and Louisiana from Hurricane Harvey--to name just a few crucial issues.
Lawmakers in Washington faced different types of storms as they prepared to return to the Capital from a summer recess. And much of the unsettled atmosphere was of their own creation.
After much contentious rhetoric--and with limited voter or industry input--Congress failed to agree on a new healthcare plan in July. After years of debate, the lack of agreement and action by lawmakers left many unanswered questions about healthcare, including a battle against a killer that takes tens of thousands of lives per year.
A National Academies of Sciences, Engineering, and Medicine (NASEM) report, sponsored by FDA, stated that approximately 90 Americans die every day from overdoses that involve an opioid. As of 2015, at least two million people in the United States were addicted to prescription opioids, and almost 600,000 had an opioid use disorder involving heroin, the report said (1).
FDA Commissioner Scott Gottlieb has made the opioid crisis a priority. In June 2017, FDA asked Endo Pharmaceuticals to voluntarily remove Opana ER from the market when postmarketing data indicated a shift in the route of abuse after the drug was reformulated. This action marked the first time the agency requested a company remove an opioid from the market. The drug was withdrawn on July 6, 2017 (2).
The NASEM report recommended a fundamental shift in the approach to prescribing practice for opioids and improved access to naloxone to combat the effects. The report also suggested that FDA consider public health impacts when making opioid-related regulatory decisions, moving beyond the traditional product-specific approach drug approval decisions, which evaluate data submitted by the drug’s manufacturer and weigh the benefits against the known risks to individual patients.
The recommendations offer some good suggestions; however, without guidance or funding from Washington, elected officals, law enforcement, and healthcare professionals in individual states, for now, are on their own to come up with solutions to the epidemic.
Before leaving for its August recess, Congress overwhelmingly passed the FDA Reauthorization Act (FDARA) approving user fees and FDA program changes needed to maintain the FDA medical product review and approval process. The fees will generate $8-9 billion over five years to support regulatory oversight of prescription drugs and biologics, generic drugs, medical devices, and biosimilars.
President Trump signed the legislation without fanfare in mid-August. His administration had called for a major increase in industry-paid fees to fully support FDA regulatory programs.
The reauthorization legislation was the result of two years of negotiations between Congress, FDA, and industry groups. The overwhelming support of the Act demonstrates that Congress can reach consensus. Perhaps they can keep that in mind as they head back to work in September to tackle a full agenda that includes funding for hurricane relief, passage of a spending bill, raising the debt ceiling, tax reform, immigration reform, and the unresolved healthcare issue.
1. National Academies of Sciences, Engineering, and Medicine, Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use (Washington, DC, July 13, 2017).
2. PharmTech, “Endo Withdraws Opioid Drug from Market,” July 10, 2017.
Volume 41, Number 9
When referring to this article, please cite it as R. Peters, “The Human Cost of Congressional Stalemates," Pharmaceutical Technology 41 (9) 2017.