While the Trump administration has painted the jettisoning of staff and regulations as good for business, there are multiple reasons it’s unlikely to work out that way.
The current U.S. presidential administration under Donald Trump has begun to eliminate many federal regulatory staff while announcing plans to dramatically cut regulations. While administration officials, including senior advisor Elon Musk and U.S. Chamber President Suzanne P. Clark have touted potential financial positives for industry, it is not that simple.
So far, the administration has forced out HHS staff, including thousands at the FDA who oversaw scheduling inspections, vaccine regulations, and user fee programs without changing the policies these staff enforced. The FDA will struggle to support reviews and approvals of drugs against the Federal Code of Regulations with reduced staff and funding. This only delays the approval of new drugs and limits post marketing safety surveillance.
As a regulatory operations specialist at the consumer health and hygiene company Reckitt, I’ve concluded that the pharmaceutical industry is unlikely to see much if any upside because of the ongoing FDA shakeup. Here’s why.
First, in the grand scheme of a company’s portfolio, a single four-year presidential term is not a long time. Companies must consider the possibility that any changes made to regulations or enforcement in this administration could be reversed in a few years’ time. To eliminate adherence to regulatory protocols—for example, maintaining current good manufacturing processes in readiness for frequent FDA inspections—only to have to reinstate them, would be costly from a business perspective. Drug manufacturers would have a difficult time trying to determine if the short-term potential cost cuts are worth the not-so-long-term risk of reversal.
Further, reducing U.S. drug regulations does not eliminate the many international standards that manufacturers are required to follow if they market their drugs in any other countries or have plans to in the future. The resources allocated to complying with these policies would still be required.
For this administration to remove enough regulations to have any significant financial impact on industry would require Congress to repeal hundreds of laws, including many that apply to sectors beyond drug manufacturing. Good clinical practices, for example, are often costly to drug developers, but easing up on these safety requirements could have unintended consequences in other areas of patient care.
From companies’ point of view, regardless of the laws governing the FDA, easing up on patient safety would cause harm and raise the risk of litigation on bases such as fraud, criminal negligence and bodily harm. The large body of data supporting patient safety practices will not go away just because this administration may want it to.
Another factor is that state legislatures have also recently begun proposing and passing regulations that are stricter than the federal legislation. California’s Proposition 65, enacted with the aim of restricting and increasing transparency around harmful chemicals commonly found in food, cosmetics, medicines and their packaging, is expected to be joined by 15 other states with a policy known as Safer States. It is an entirely possible scenario that for drug manufacturers to continue selling in many states, they will still have to abide by these laws even if regulations are dropped federally.
While there are many individuals within the pharmaceutical industry who care deeply about the safety of patients and the public, historically, drug companies have put patients at risk when it’s helped their bottom line. Altruistic motives are not sufficient to keep the drug supply safe.
A more realistic argument for drug manufacturers to continue following current testing and safety practices is that for each law in place to regulate the manufacturing, marketing and distribution of drugs, there is an unfortunate story of how that law came to be. The sulfanilamide disaster of 1937, NECC’s meningitis outbreak, and the thalidomide tragedy are a few memorable examples of the dangers associated with failing to meet today’s safety and efficacy standards. Beyond temporary and permanent patient harm, stories like these have damaged brand loyalty, driven down the price of market shares and imposed significant costs in recalls. No manufacturer wants to be stuck in that nightmare. Which is why removing safety and quality practices would not result in the cost savings the administration is touting.
Finally, while this administration has begun to slash regulators and agency budgets, officials have also proposed multiple new regulations on the industry. These include banning red dye no. 3 and televised pharmaceutical advertisements, implementing price controls, and attempting to enhance national security and the drug supply chain through the BIOSECURE Act. These proposals conflict with the overarching sentiment to cut back on regulations and regulators.
While these sweeping changes are troubling to regulators and the public alike, there is not a clear path to removing many of the safety standards put in place that would save the trillion-dollar drug manufacturing industry money without significant risk. In this tumultuous time, pharmaceutical executives should continue to prioritize following evidence-based testing and protocols regardless of the current laws and regulations. Ensuring drug quality should never be considered a burdensome or unnecessary cost; rather, it increases drug access, shortens approval timelines and minimizes potential consequences.
