Why Deregulation Won’t Deliver for the Pharmaceutical Industry
The current U.S. presidential administration under Donald Trump has begun eliminating federal regulatory staff and announced plans to dramatically scale back regulations. While administration figures like senior advisor Elon Musk and U.S. Chamber President Suzanne P. Clark emphasize potential financial benefits for industry, the reality is far more complex.
At the Department of Health and Human Services (HHS), thousands of FDA staff responsible for critical functions—such as inspections, vaccine oversight, and user fee programs—have been pushed out without altering the policies they enforced. This creates a major bottleneck: the FDA now lacks the personnel to uphold existing standards, slowing drug approvals and weakening post-market safety surveillance.
As a regulatory operations specialist at Reckitt, a global consumer health and hygiene company, I see little reason to believe the pharmaceutical industry will benefit from this disruption. Here’s why.
Short-Term Gains, Long-Term Risks
A single four-year presidential term is a brief moment in the life cycle of a pharmaceutical product. Regulatory rollbacks introduced now could easily be reversed by a future administration. Companies that scale back compliance with current good manufacturing practices may face high costs when forced to restore those systems. The risk and uncertainty outweigh any short-term savings.
International Standards Still Apply
Even if U.S. regulations are relaxed, global manufacturers must continue to meet international standards to sell products overseas. Regulatory compliance remains a fixed cost for companies that operate internationally, regardless of changes in U.S. law.
Congress, Not Just the White House
For deregulation to significantly reduce costs, Congress would need to repeal hundreds of laws—many of which extend beyond pharmaceuticals. Good clinical practices, while expensive, safeguard patients and maintain the integrity of clinical data. Weakening these standards risks broader harm, both medically and legally.
Companies also face potential legal exposure if patient safety is compromised. Reducing safeguards can lead to lawsuits for fraud, negligence, or injury. The data supporting today’s safety standards won’t disappear with a change in administration—and neither will the consequences of ignoring it.
States Stepping Up
State governments are already enacting stricter laws than the federal government. California’s Proposition 65, which mandates disclosure of harmful chemicals in products, is one example. Several other states are poised to follow with similar measures under the Safer States initiative. Even if federal regulations are rolled back, companies may still need to comply with more stringent state-level rules.
History as a Cautionary Tale
The pharmaceutical industry has seen what happens when safety protocols are ignored: the 1937 sulfanilamide disaster, NECC’s meningitis outbreak, and the thalidomide tragedy are just a few of the painful lessons. These events led to stronger laws, but they also serve as reminders of the human and financial toll of negligence. Beyond harming patients, these incidents damaged reputations, triggered stock drops, and led to costly recalls.
Abandoning safety and quality protocols in pursuit of savings is a gamble few companies can afford to make.
Mixed Messages from the Administration
Even as the administration cuts staff and funding, it has proposed new regulations—like banning red dye no. 3, regulating pharmaceutical advertising, implementing price controls, and strengthening the supply chain under the BIOSECURE Act. These efforts contradict the broader deregulatory message and add to the uncertainty facing manufacturers.
