FDA-A Service to Whom?

The FDA Provides a Service to Whom?

Most Americans confidently bite into an apple or take an aspirin believing that the Food and Drug Administration (FDA) is doing its job, but in recent years, this entity seems to be in need of a thorough reorganization.  The FDA has a huge responsibility to test and approve safe pharmaceutical drugs for the US.  Through my research, I will present some alarming data that implies the FDA is biased towards pharmaceutical corporations and compromised and no longer a reliable overseer of the people’s health.  I believe the FDA is suffering from mismanagement, pressure, and greed, and is no longer serving the best interest of the American people.

At first glance, the origins of the FDA were based on a noble premise.  The official FDA website, explains that, having originally spun off of the Agriculture Culture division of the Patent Office in 1848, in 1906 it was more fully organized into a consumer protection agency when the public expressed outrage over the unhygienic conditions in a Chicago stockyard.  The history includes the fact that the “position of chief chemist of the Bureau of Chemistry evolved into that of the commissioner of food and drugs.”   Per the FDA website, “the Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.”  They also state that “the FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable…” According to Roberts, “under its original charter, the 1938 Federal Food, Drug and Cosmetic Act, the agency was broadly charged with ensuring the safety of drugs before they are marketed.  Prior to this, “companies could test drugs on people without notifying the agency and without obtaining voluntary and informed consent (Roberts).”  For my research I have focused on the Drugs division of the FDA which is defined as “human drugs and therapeutic biologicals (proteins and other products derived from living sources used for therapeutic purposes)”

Looking back, the office of the FDA was a necessity.  Prior to 1962, there was no mechanism in the US to approve drugs before they went to market.  In 1961, it was discovered that the drug Thalidomide was causing horrifying birth defects.  Amendments were passed thereafter “granting oversight of drugs to the FDA and compelling manufacturers to prove that their drugs are safe for public consumption.” (McIntyre ).  To avoid fraudulent products and devastating side effects, the FDA is necessary to ensure the public is not used as a testing lab for new products. 

Since its inception, the job description of the FDA hasn’t changed in essence, but it has been amended several times.  In 1982 new regulations were approved to speed the drug approval process.  The current average time being two years, the FDA planned to cut that time by at least 6 months (Roberts).   This amendment came about due to pressures from physicians and pharmaceutical companies because new drugs were available overseas in shorter time frames than in the US (Roberts). “In 1992, Congress came up with a new funding mechanism where the pharmaceutical industry negotiated fees in exchange for a quicker drug approval process (Jadhav).  Today, there are four new programs added to the FDA to speed up the development and approval of new drugs.  These programs are known as the fast track designation, breakthrough therapy designation, accelerated approval, and priority review.  With these amendments, we wonder if the office of the FDA is now more focused on approving drugs for the benefit of the drug company rather than the benefit of the American people. 

Through its historical evolution, the FDA has undergone much pressure from many sides.  The FDA has gotten sidetracked from its purpose of protecting the American people.  They are besieged by many distracting factors, such as paperwork and human relations, and are caving to greed, peer pressure, consumer pressure, government pressure, and national pressure.  For instance, on a global scale, the FDA is pressured by the competition between other countries.  As the leader of the free world, and the headquarters of many major drug companies, we must remain the first in everything including the drug market.  Early on, the FDA was accused of depriving the American people of life-saving drugs due to their lengthy drug-approval process. (Roberts).  In 1991, President George Bush cited the FDA’s drug-approval process as a burdensome federal regulation. (Roberts).  They had earned the reputation of being the” toughest drug regulator in the world”.  In addition, most pharmaceutical companies are multi-national and can choose which country handles their approval process.  I’m not even sure how that can be deemed legal.  Nonetheless, faced with losing these companies due to criticisms of approval times, the US was pressured into revising its approval process.  “Today, the FDA’s approval process is, on average, faster than that of any other major nation.  In 2015, 64 percent of innovative new drugs were approved by the FDA before they received approval in any other country in the world. The US has definitely responded to the international pressure to excel in drug approval.   Whether or not these changes benefit Americans is another matter entirely.

In addition to national pressure, the FDA is pressured by the scientific community as a whole to rush testing and approve drugs sooner.  These other branches are pressured by members of the government to produce more pharmaceuticals because those members are under pressure from the drug-dependent unhealthy American people.  Many Americans have come to depend on the latest in advancement in pharmaceuticals to fix their health problems.  Instead of addressing their diet and exercise regime, they pressure the FDA to make new drugs more readily available to them.  Money talks and the mighty American consumer dollar is being heard loud and clear.

Being at the top of the charts in approval times, the American consumer believes the FDA to be a superior organization.  However, it is rife with problems and mistakes.  Many American consumers are becoming aware of the many drug recalls that are announced and the subsequent lawsuits that soon follow.  The history of the FDA is a bloody one in terms of failed drugs that they had approved that have harmed people.  Today the approval process consists of three steps.  The first step is industry-sponsored research that uses laboratory and animal testing to determine if the product is reasonably safe.  The product then moves forward into Phase 1 of clinical trials, which tests the drug in 20-80 healthy patients.  If the drug is ‘not unacceptably toxic”, it proceeds to Phase 2, which consists of several hundred to about 3,000 patients.  A New Drug Application is then submitted, and the FDA must look at the results, including safety and effectiveness, side effects, how the body uses the drug, and manufacturing. 

Under the new Prescription Drug User Fee Act, the FDA is now on a timeline and must review and act on at least 90% of these applications within 10 months of receiving them.  Amazingly, a drug is deemed effective and safe if “its benefits outweigh the known risks”. This does not even take into consideration the accelerated Fast Track approval system which bases the approval off of a single Phase 2 study and then the unsuspecting public is subjected to “post approval testing” to ultimately determine the product’s safety and effectiveness.  In other words, the drug is pushed through the system with fees paid by the pharmaceutical companies, with limited data or findings, and then sold to unsuspecting consumers to determine if it’s actually a safe drug.  In an article from the Ecologist titled “Watchdogs, Poodles, Guinea Pigs, and Drugs,” it was stated that “these fees (from the pharmaceutical companies) now fund more than half the agency’s critical review process.” (Watchdogs)  So how safe are these drugs approved by the FDA?

 A quick google search of drug recalls will supply you with many hours of laborious reading.  I will recap the top drug “mistakes” made by the FDA. 

• Fen Phen was a popular weight loss drug.  In 1997, Fen-Phen was recalled after 24 years on the market.  An estimated 65 million people took this drug and consumers experienced heart disease and other pulmonary problems.  50,000 Fen-Phen victims have filed lawsuits and victims have been awarded close to $14 billion. 
• Baycol was prescribed for high cholesterol.  It was recalled in 2001 in responsible for more than 100,000 deaths and about as many lawsuits. It caused kidneys to be clogged with protein from dying muscle tissue.  Litigation-related damages totaled $1.2 billion.
• Vioxx, an arthritis pain drug, was recalled in 2004 after being prescribed to more than 20 million people and is considered to be the largest drug recall in history.  Vioxx affected 140,000 people with serious coronary heart disease.
• PPA (Phenylpropanolamine) was a drug used for many conditions including dieting, cold medicine, and even psychological disorders.  It was recalled in 2000 after at least 60 years on the market even though it was never formerly approved by the FDA.  It was linked to cardiac events and stroke.  More than 25,000 lawsuits have been filed, and awards for damages numbers in the hundreds of millions, if not billions. (McIntyre)

This is in no way a complete list, this essay will not provide space or time for that. But suffice to say that there has been much damage to American people that could have been prevented by the FDA. 

Besides the thoughts already presented here, such as pressure to speed up the approval process, and the conflict of interest where pharmaceutical companies are paying the FDA, there looms a bigger problem that seems to attribute to much of the FDA’s issues.  This surprising problem lies in something so simple as paperwork.  An article by Leslie Roberts, titled Speeding New Drug Approval: Aid to Patients or Industry?, brings out the disorganization and bad business practices the FDA has perpetuated, such as mounds of untouched adverse reactions reports. This article states that at the time it was written, the FDA had a backlog of 7000 reports that had not even been checked.  Also, 44% of the reports had been lost or mislaid.  How can we depend on such a disorganized entity to ensure our health?

Based on the evidence I have presented, it is conclusive that the FDA is in need of serious reorganization.  The unreliability of their testing methods, their paperwork problems, and their biased approvals leave us with no doubt.  We have not even broached the subject of how testing 1000 people out of a population of 1.8 billion people can possibly determine safety for all.  We have not the time to discuss how many FDA-approved drugs are now tested in other countries instead of here in America, or how generic drugs do not have to go through the same approval process.  Suffice to say, the FDA has strayed from its original purpose and is facing many issues.  We do know this: the FDA is a huge, influential organization with much control.  With that control comes much responsibility.  They owe it to the American people to approve products that are safe.  First, do no harm. 

Works Cited

“FDA Is Not the Problem.” US Official News Release. Lexisnexis.com.cosc.idm.oclc.org. Plus Media Solutions, 10 Mar. 2016. Web. 30 Apr. 2017. <http://www.lexisnexis.com.cosc.idm.oclc.org/hottopics/lnacademic/>. 

Jadhav, Adam. “You Get What…Drug Companies Pay the FDA for Its Approval Process.” St Louis Post-Dispatch (Missouri). N.p., 25 Mar. 2007. Web. 30 Apr. 2017.

McIntyre, Douglas A., Jack Campbell, and Ashley Allen. “The Ten Worst Drug Recalls In The History Of The FDA.” 247wallst.com. N.p., 10 Dec. 2010. Web. 30 Apr. 2017. <http://247wallst.com/investing/2010/12/10/the-ten-worst-drug-recalls-in-the-history-of-the-fda/>.

Roberts, Leslie. “Speeding New Drug Approval: Aid to Patients or Industry?.” Bioscience, vol. 32, no. 11, Dec. 1982, pp. 839-844. EBSCOhost, search.ebscohost.com/login.aspx?direct=true&AuthType=cookie,ip,url,cpid&custid=s9518177&db=8gh&AN=28051615&site=ehost-live. Accessed 7 April 2017.

 “Watchdogs, Poodles, Guinea Pigs and Drugs.” Ecologist, vol.36, no. 10, Dec. 2006, p.12 EBSCOhost, search.ebscohost.com/login.aspx?direct=true&AuthType=cookie,ip,url,cpid&custid=s9518177&db=8gh&AN=23131469&site=ehost-live.   Web. 30 Apr. 2017.

Off-Topic. With all of the talk about the latest FDA approval, I was reminded of the college research paper I wrote in 2017.

5 May, 2017