Tag:Big Pharma
The “Revolving Door” of the FDA and its Public Safety Impacts
It’s no secret that prior Food and Drug Administration (FDA) regulators, who managed drug approvals, often get comfortable, high-paying jobs at the same companies that produce those drugs and products, nor is it anything new. This is the “revolving door” of the FDA. The “revolving door” refers to the movement of employees from regulatory agencies to the private corporations they regulate. This phenomenon occurs at every level of employment from standard regulators to senior staff and high-ranking employees. In fact, every FDA commissioner since 2000 has gone on to work for a large corporation regulated by the FDA, which raises ethical concerns regarding the agency’s ability to regulate drug manufacturers without any conflict of interests or corruption. Despite the FDA’s claims that its ethics rules, in accordance with federal laws, prevent FDA regulators and employees from engaging in conflicts of interest by accepting these types of employment positions, the revolving door remains prevalent between the FDA and private pharmaceutical companies. Not only does this raise concerns about conflicts of interest and the integrity of regulatory decisions, but it also negatively impacts the country’s public health and safety because drugs and other pharmaceutical products are introduced to the market with FDA approval that otherwise should not have been due to dangerous side effects, addictive nature, or other perverse factors pertaining to the specific products.
Talk Kickback to Me: Healthcare Provider Remuneration by Big Pharma
Recently, pharmaceutical companies are gaining increased notoriety for violations of the False Claims Act, the Anti-Kickback Statute, and general fraudulent practices directed toward physicians and medical care providers with the intent to increase profits. In 2019, Avanir Pharmaceuticals settled with the Department of Justice to pay more than $108 million of criminal penalties and civil damages for engaging in kickbacks with physicians, and misleading marketing of their drug Nudexta for unapproved purposes. Then, in May of 2021, Incyte Corp., a Delaware-based pharmaceutical manufacturer agreed to pay $12.6 million for unspecified damages arising under a violation of the Federal False Claims Act for improperly using an independent foundation to cover copays of individuals consuming Incyte’s cancer drug, Jakafi. Despite widespread prosecutions against pharmaceutical drug manufacturers, and the fraud deterrent provisions of the False Claims Act, the risk of fraud and remuneration still runs high in relationships between healthcare professionals and pharmaceutical companies.
Can Congress Regulate Big Pharma?
Drug companies need to fund the research and development necessary to create better products. This means that pharmaceutical companies have fought for years to maintain control over the prices of said drugs. But this standard is being challenged with a new bill that was introduced to the House of Representatives on June 25, 2018.