Has the growing reliance of the U.S. Food and Drug Administration on industry user fees changed how the pharmaceutical and medical device industries influence FDA regulation? A review in The New England Journal of Medicine charts changing industry influence from the Prescription Drug User Fee Act (PDUFA)of 1992 to the recent sixth re-authorization of PDUFA by President Trump this year. The authors conclude that although 25 years of industry funding have shortened regulatory timelines, the user-fee model has fundamentally changed the way the FDA interacts with the drug industry. These changes may increase the risk that unsafe or ineffective drugs or medical devices enter the market.
Consumer access to effective and affordable medicines is an imperative for public health, social equity, and economic development, but this need is not being served adequately by the biopharmaceutical sector, says a new report from the National Academies of Sciences, Engineering, and Medicine. The report offers recommendations to improve the affordability of prescription drugs without discouraging the development of new and more effective drugs for the future. “Over the past several decades, the biopharmaceutical sector in the United States has been successful in developing and delivering effective drugs for improving health and fighting disease, and many medical conditions that were long deemed untreatable can now be cured or managed effectively,” said Norman Augustine, chair of the committee that conducted the study and wrote the report. “However, high and increasing costs of prescription drugs coupled with the broader trends in overall medical expenditures … are unsustainable to society as a whole. Our report seeks to address the market failures that currently permeate the biopharmaceutical sector, such as lack of competition due to distortions in the application of the patent protection process, the imbalance between the negotiating power of suppliers and purchasers, and the convoluted structure of the supply chain. Although changes within the current system will be demanding, they are likely to better serve the nation.”
A Washington Post 60 minutes investigative expose revealed that Trump’s nominee to head the Drug Enforcement Agency, Tom Marino, a Republican from Pennsylvania had led a successful effort in the House of Representatives to strip the DEA of its most potent weapon against large drug companies suspected of spilling prescription narcotics onto the nation’s streets. The revelation forced Marino to withdraw and Trump to start again in pursuing his long-promised campaign against opioid misuse. The story suggests two lessons. First, corporate influence in Congress is so strong that even in an opioid epidemic, the drug industry can persuade Congress to deregulate to protect its profits. Second, the power of investigative journalism continues to be an important check on abuses of authority.
A report released by the minority members of the US. Senate Homeland Security and Governmental Affairs Committee provides new information regarding the significant efforts the pharmaceutical company Insys has undertaken to reduce barriers to the prescription of Subsys, its powerful fentanyl product. These efforts include actions to mislead pharmacy benefit managers (PBMs) about the role of Insys in the prior authorization process and the presence of breakthrough cancer pain in potential Subsys patients. An internal Insys document suggests Insys apparently lacked even basic measures to prevent its employees from manipulating the prior authorization process and received clear notice of these deficiencies.
In May, Maryland became the first state to take action against the alarming trend of price gouging of off-patent brand-name and generic drugs, writes Jeremy Greene in an op-ed in The Washington Post. The state’s concise new law, which permits the attorney general to argue in front of a court when the price of an older essential medication increases so precipitously as to “shock the conscience,” passed with overwhelming bipartisan votes and broad popular support. The generic pharmaceutical industry would prefer to see it overturned. While the problem of pharmaceutical pricing is felt most keenly in newer specialty drugs that can cost more than $30,000 a year, interpretations of federal patent law limit the ability of states to protect residents from price increases in these newer drugs whose monopolies are protected by patents.
Novo Nordisk (Denmark) has agreed to pay $58.65 million to end a federal investigation by the US Department of Justice (DoJ) related to the company’s diabetes medication marketing practices, reports Bloomberg News. The investigation was launched in February 2011 into sales and marketing activities concerning Novo Nordisk’s leading type 2 diabetes drug Victoza. The financial terms of the agreement mean that Novo Nordisk will pay about $46.5 million as settlement to the federal government and to US states responsible for reimbursing Victoza under the Medicaid program. Furthermore, Novo Nordisk has agreed to pay $12.15 million to resolve complaints lodged by the US administration on behalf of the FDA. The alleged off-label marketing unnecessarily increased the costs for government healthcare programs while allegedly endangering patients, according to the whistleblower complaints and the government.
Reuters reports that the European Commission has started an in-depth investigation of Bayer’s planned $66 billion takeover of U.S. seeds group Monsanto, saying it was worried about competition in various pesticide and seeds markets. The deal would create the world’s largest integrated pesticides and seeds company, the Commission said, adding this limited the number of competitors selling herbicides and seeds in Europe. If the deal goes through, the newly merged company will be one of the largest agrochemical firms in the world and could put 90 percent of the world’s food supply in the hands of only four multinational corporations.