Could streamlining FDA approval process reduce patient safety?
President Donald Trump has proposed “streamlining” the regulatory process for newdrug applications, which may prove to be beneficial in reducing the end consumer price point on new therapeutics and drugs, decrease the cost of research and development, and allowfor smaller biopharmaceutical companies to effectively bring their products to market without the involvement of larger stakeholders. However, I amleft with great skepticism when it comes to modifying an investigational process that has been immensely improved since the 1960s. If any of this “streamlining” eases the standards to which clinical trials are held today, we could be placing patients at risk and be left with ineffective drugs flooding the markets.
Clinical trials aim to protect the public frominadequate, unethical and dangerous therapeutics by conducting a series of controlled investigations which examine the safety, tolerability and side-effect profile of any new drug developed with the intention to be marketed for human use. The Food and Drug Administration (FDA) then uses these clinical trials, and the results which they provide, as their assessment tool to determine approval. The FDA has held the responsibility to protect the public’s health by assuring adequate safety, efficacy and security of human drugs in theUnited States since 1906. Through regulations, the FDA ensures that the health benefits of any drug sold within their jurisdiction outweigh their known risks.
President Trump issued an executive order on Jan. 30 aimed at decreasing regulations— eliminating two regulations for every new one issued. This has the potential to greatly relax the standards of drug approval. In a meeting held by Trump and pharmaceutical executives he stated,“We’re going to get the approval process much faster,” which is a dangerous statement to make if the rationale behind current regulations are not considered, especially if the solution is to simply eliminate the requirements for FDA approval. Reducing the existing standards for drug approvalwould allowfor a “faster process,” and itwould also allowfor more ineffective drugs to be marketed and cause a reduction in the safety standards the FDAwas established to maintain.
In an effort tomove toward improvement, I believe a balance must be struck between determining safety and efficacy among a controlled investigation, while reducing the excessive cost of bringing new drugs to market. Safety must remain paramount, and any proposed improvements cannot be forced overnight or with the swipe of a thoughtless signature.
Just as time has gone into improving this investigational process to identify contraindications and drug side effects, the process of deregulation must utilize this same careful and evidence based approach.
In order for a drug to be approved, the benefit of the therapeutic must outweigh the potential or identified risk to the patient. This is called the benefit-risk ratio. If the standards of efficacy, which can be correlated to patient benefit, is altered in this equation, the allowable side-effect profile may increase.
Trump’s cuts could reduce the cost of drug development, however, that cost reduction will be consumed by the increased cost of health care due to the treatment of the adverse drug reactions and the indirect cost of ineffective treatments that should have never been marketed.
Clinical trials and the FDA’s regulations do not restrict or identify every harmful drug from being marketed, however, the regulations which have been established have allowed physicians and patients to be more informed about their medications, and drove medicine toward innovation and cures.
As it stands, the medical community lacks knowledge on the long-term effects of many of the drugs on the market, and ifwe choose to support a streamlined version of clinical trials and drug development to save the pharmaceutical companies a buck, I amcertainwe will learn a lot less about future medications, decrease safety, and be far less innovative as a country.
Anthony J. Messina, of Port St. Lucie, is a SOCRA certified clinical research professional.