The FDA Red Tape: How Tight Drug Controls are Harming Patients

By Kristina Kohler

While the intentions for a thorough drug approval process are good, looser FDA regulations would result in medicine reaching ill patients faster without a significant compromise in safety.

Medical innovation is a keystone of our modern good society. Over the last century, progress in medical science has been marvelous. From the discovery of antibiotics to the sequencing of the human genome, promising treatments to atrocious human ailments have never been closer.

Time is of the essence in getting critical treatments to patients.

However, our progress in medical research has not been paralleled in actual patient treatments. In fact, there’s an alarming discrepancy between available treatments and breakthrough pharmaceutical discoveries. What’s the culprit of this lethal problem? It’s actually the very agency whose goal is the health and safety of society: the FDA. Since 1906, the FDA has been keeping Americans safe through regulating the drug market. By its thorough research and stringent controls, the FDA strives to ensure the safety of every drug before it is placed on the market. Needless to say, this is paramount to the well-being of society.

On the other hand, overly stringent guidelines, combined with a lack of FDA resources for its staggering task, have given rise to a major dilemma. Patients’ need for timely, life-saving treatment goes unmet due to the swath of red tape encompassing the FDA approval process.

Leukemia and Conquistadors: Two Examples of the Red Tape

I was first introduced to this issue in 2016 when a dear family friend had late stage Acute Lymphoblastic Leukemia. She had fought it valiantly for six years, but her condition continued to decline. Many failed treatments ultimately left one treatment option: a clinical trial for a CAR T-cell infusion. She and her family prepared to move out-of-state for the trial. But at the last minute, the trial was suspended by the FDA due to high death rates. After this last hope was taken from her, my friend chose to stop all of her cancer treatments. Though it was apparent that the CAR T-cell procedure needed development, I still wonder whether it could have saved my friend’s life.

The marvels in scientific progress and the drug predicament in general are not unlike an issue seen centuries ago: tragic inflation during the Age of Exploration. During the 15th and 16th centuries, improvements in sailing technologies in part led to the discovery of "brave new worlds". The Americas were opened up to plunder, venture, and trade by the Conquistadors of Spain and others. None of these journeys could be made without significant venture capital. However, the wealth of material resources awaiting explorers of the New World more than paid for the initial costs-- or so one would think. But the resulting influx of gold and silver in Spain caused a severe economic collapse. The economy was simply unprepared for such materials. Similarly, the ventures of science are opening up brave new worlds of possibilities in medical treatment. However, the current standing of the FDA is unequipped to handle the wave of new drug applications. A major drug lag has resulted, and patients are left mostly empty-handed while the riches of medical research continue to multiply.

Artist depiction of gold-laden Spaniards in the New World

The FDA’s thoroughness is grounded; certainly, the risks associated with a “bad drug” on the market can be severe. However, the omission of “good drugs” from approval can be just as consequential, if not as publicly apparent. While the intentions for a thorough drug approval process are good, looser FDA regulations would result in medicine reaching ill patients faster without a significant compromise in safety.

A brief overview of the FDA approval process

The Approval Process Itself

What do “looser regulations” mean, exactly? To understand the possible solutions, it’s important to know the general drug approval process. First, the drug is developed and goes through animal testing. If this is successful, it is followed by the submission of a investigational new drug application. The drug then enters the 3-phase clinical stage. Each phase of the process involves more patients, and explores safety, quality, and effectiveness on different patient groupings. Following the clinical stage, the new drug application process begins; meetings between the pharmaceutical companies and FDA officials, paperwork reviews, and facility inspections follow. At last, the drug is approved and made available to the public.

Our FDA approval process drags behind much of the modern world’s drug quality control mechanisms. This phenomenon is called “drug lag”; numerous examples provide evidence. For instance, the US General Accounting Office studied the approval of 14 important drugs between 1975 and 1978; “Of these 14 important drugs, all but one were available earlier in at least one foreign country before they were available in the United States. “ Additionally, all 14 had shorter approval times in foreign countries (Grabowski, 1982). Even today, the drug lag continues. While public policies and legislation such as the PDUFA act have expedited the approval process, there’s still much to be desired in timely drug delivery.

Possible Solutions

Flexibility in clinical trials is one step towards a looser regulation process. The clinical trial stage, understandably, can be the most lengthy and challenging step of drug approval. In a human model, it's essential to observe the effects of various drugs alone and in combination with other drugs. However, the clinical process can be improved by spreading the facilitation responsibility to other federal subcommittees. The FDA can still have the final say on a drug's clinical success, but the staggering task of ensuring drug safety all throughout the clinical stage should be shared and delegated with other parties. Combining this with less stringent standards for clinical trial drug suitability and increased post-market drug surveillance will ultimately result in a net benefit for ill patients and the FDA itself.

Our public policies can also be changed to improve drug regulation. From my personal background in a biochemistry cancer research laboratory, I can tell you that science is expensive! When one considers the amplified cost of researching and testing all the different drugs undergoing approval, it's no wonder why the FDA comes short of the resources it needs. However, one specific act of legislation known as PDUFA requires a "user fee" at the hands of pharmaceutical companies to mitigate FDA research costs. The act has been a great help in expediting the approval process. However, the user fee has increased with successive renewals of the act. This hurts independent, smaller drug companies and encourages monopolizing "big pharma"; mergers are quite common in the pharmaceutical industry. It's worth noting, however, that shutting down small drug companies hurts the ingenuity and creativity of the industry. While government legislation can be a powerful force in hastening the drug approval process, it must include creative economic solutions to distribute the financial burden of research. If these policies are underscored by a greater tendency to err on the side of approval rather than "good drug" omission, we are bound to see positive changes in the timeline of new drug approvals.

In sum, society's progress in medical science has been juxtaposed by glaring unmet needs in drug treatments. Standing betwixt the two is the FDA, whose primary duty is to regulate the safety of the drug market while approving drugs in a timely manner. However, the stringent controls and lack of FDA resources have left many desperate patients without life-saving novel treatments coming from a booming research community. To alleviate the issue, the FDA should loosen its drug regulation process by allowing more freedom in clinical trials, increasing post-market surveillance, and delegating clinical trial responsibilities. Furthermore, legislation which favors approvals and distributes federal research costs without penalizing small pharmaceutical companies would serve to meet patients' need for timely, novel treatments. These changes combined can open up new pathways for marketing life-saving drugs. As a whole, scientific research discoveries can be better paralleled by effective treatment options by changing the intermediary FDA approval process.

Sources

• Fisher, Douglas (December 1989). "The Price Revolution: A Monetary Interpretation". The Journal of Economic History. 49 (4): 883–902.
• Grabowski, Henry G. Public Policy and Pharmaceutical Innovation. MMRR, 4 Sept. 1982, www.ncbi.nlm.nih.gov/pmc/articles/PMC4191286/.
• LaMattina, John. “Is The FDA Being Compromised By Pharma Payments?” Forbes, Forbes Magazine, 7 Aug. 2013, www.forbes.com/sites/johnlamattina/2013/08/07/is-the-fda-being-compromised-by-pharma-payments/#1a46f8242830.

Image Credits

• "3 things to consider when taking medication" Shine365- Marshfield Clinic
• "FDA Pharmaceutical Development and Approval Process" Next Generation PharmaAmerica
• "Story Of Atahualpa: The Last Emperor Of The Inca Empire" Realm of History