Is the FDA Working for Drug Makers or Drug Users?
The U.S. Federal Food and Drug Administration’s (FDA) Origins The 1906 Pure Food and Drugs Act was the first act that established the federal consumer protection agency. However, its foundation was not enough to stop low-quality food and drugs from flooding the market. In 1938, Congress passed the Food, Drug, and Cosmetic Act, in response to public outrage. This gave the FDA greater authority to protect U.S. citizens.
Early Success
Despite its weaknesses, the FDA, which was completely funded by taxpayers, did at least once protect consumers. Rejecting the drug Thalidomide This protection is probably one of the most impressive examples. Many countries have approved Thalidomide, which was used in the 1950s to treat morning sickness in women who were pregnant.
Dr. Frances Oldham Kelsey (one of a handful of FDA medical officers at that time) was assigned the task of reviewing the thalidomide request. Despite constant pressure from the drug company, Dr. Kelsey refused to approve the application because she felt it lacked scientifically reliable evidence of the drug’s safety.
A year after thalidomide had been introduced to other countries, researchers found a link between it and a serious birth defect that affected thousands of babies. Dr. Kelsey was right to stand by her assertion. In 1962, President Kennedy conferred on Dr. Kelsey the President’s Award for Distinguished Federal Civilian Service.
AIDS and the introduction of ‘User Fees’
In the 1960s, 1970s, there were social movements in the United States and other developed countries that challenged established norms regarding sexual behavior and relationships. In the 1980s, the AIDS crisis struck the United States and other countries. This prompted government agencies and pharmaceutical firms to dedicate enormous resources to developing new drugs to fight AIDS.
With Celebrities and sports stars die from AIDS-related complications. AIDS activists protested at long delays in receiving FDA-approved HIV drugs. They protested in mass throughout the country, claiming that they had been denied experimental FDA-approved HIV drugs for a long time. thousands of lives were lost each year due to delays in the FDA’s drug approval process. Protests And the enormous lobbying done in Congress proved to be very effective.
Congress passed the Prescription Drug User Fee Act, (PDUFA) in 1992. It allows drug manufacturers to pay FDA. “user fees” To speed up the process of reviewing drug applications.
The outcome was significant: The FDA’s new drug review staff Increasing This has resulted in a reduction of 50% in the new-application review process and an increase of 33% in the number each year of approved medicines.
Essentially, the PDUFA of 1992 started the FDA’s transformation from providing oversight to providing review services for the drug industry—and from being solely taxpayer-funded to partially industry-funded. The FDA collecting user fees from drug companies is similar to referees receiving lucrative fees from professional sports teams. The FDA pays more for user fees from larger pharmaceutical companies. The FDA is therefore more dependent on these fees to operate, and the more influential they are. “Big Pharma” Companies are.
A peer-reviewed Article The British Medical Journal, (BMJ) quotes Donald W. Light of Rowan University, New Jersey as saying: “being largely funded by fees from the companies whose products it is charged to evaluate is a fundamental conflict of interest and a prime example of institutional corruption.” Light has spent decades studying drug regulations.
Approval Fast-Track ‘Breakthrough Therapies’
FrFrom 1993 to 2016, the FDA collected user fees from pharmaceutical companies. Increased by 300%—from around $29 million to $884 million. As the drug makers’ payment to the FDA became larger, so too did their influence over the FDA’s drug approval process.
The PDUFA was passed in order to accelerate the process. However, the introduction “Advancing Breakthrough Therapies for Patients Act” The 2012 process was simplified. It allows certain drugs to be quickly approved, breaking the traditional drug approval process.
Two criteria are required to qualify a drug for approval “breakthrough therapy” These are: It is designed to treat serious, life-threatening illnesses. The preliminary clinical evidence suggests that there may be improvements over existing treatments.
Who is the authorized to grant the authorization? “breakthrough therapy” To be labeled as a new medication? The Secretary of Health and Human Services. The secretary has 60 days from the request of the drug developer to decide whether the drug should be labeled a breakthrough therapy.
In addition, the Secretary of HHS must hire an independent entity to evaluate the FDA’s breakthrough therapy review process and report to Congress on an annual basis.
The FDA was established in July 2012 and lasted until December 2015. Approved 40 of the 384 Breakthrough therapy requests
However, “improvement over existing therapies” This does not necessarily mean that there are no safety or toxicological concerns. The following steps can be used to simplify the process “breakthrough therapy” Under the umbrella, drugs seeking fast-track approval are often not subject to clinical or preclinical studies that present valid long-term or comprehensive safety and toxicology data. More drug recalls are therefore inevitable.
What’s Next?
A study by (pdf) published in The BMJ in June, “in 2020, 68% of drug approvals in the United States were through expedited pathways.” New drugs have been approved faster, are more likely be withdrawn from safety, have a black-box warning and have one or more dosage forms that have been discontinued by the manufacturer.
In 2021, the FDA gave fast-track approval to the Alzheimer’s drug AduhelmBut it is there. “unproven” Many experts, including FDA advisory panel members, were asked to review the Aduhelm application.
Pfizer’s COVID-19 vaccine Comirnaty also gained full fast-track approval. There were also numerous scientific reports throughout 2021-2022. patient reportsHearings before Congress and the House on safety of this vaccine. What is the potential for long-term harm? It is not surprising that we don’t know the long-term effects of this.
In October 2022, the U.S. Congress reauthorized the PDUFA for the sixth consecutive time. But when the PDUFA changed the relationship between the FDA and the drug companies, it also changed the FDA’s relationship with taxpayers. Is the FDA able to protect taxpayers if a large part of its budget comes directly from Big Pharma? Is the end in sight for the endless cycle of new drugs being approved and recalled drugs?
The history has repeatedly shown us that people make foolish decisions that can cause injury to themselves and others for the greater good. A new law that challenges the PDUFA status is definitely warranted. The question is, who will be able to introduce it?
The opinions expressed in this article do not necessarily reflect those of The Epoch Times. Epoch Health encourages professional discussion and friendly debate. Follow these guidelines to submit your opinion piece. Use our form below.
Dr. Xiaoxu Sean Lin, an assistant professor in Biomedical Sciences Department at Feitian College – Middletown NY. Lin is also an analyst for Epoch Media Group and VOA. Dr. Lin was a U.S. Army microbiologist. Dr. Lin also belongs to Committee of Present Danger: China.
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