Examining the FDA and Drug Approval

FDA and Drug Approval Header

Every day, 113 Americans die from drug-related overdoses.[1] In 2011, 43,403 lost their lives in alcohol-related deaths.[2] Drug abuse knows no bounds and favors no one person over another, but there are certain risk factors that make addiction a more likely consequence for certain users, such as:

  • Having a genetic predisposition handed down to you by family members with substance abuse problems
  • Being a man, which poses a twofold risk compared to being a woman
  • Having mental health problems
  • Receiving pressure from peers to use drugs or drink, either at all or more than you are comfortable with
  • Having poor family relationships and involvement with loved ones
  • Experiencing feelings of loneliness, anxiousness or depression
  • Using drugs that are highly addictive in nature[3]
Mental Illness StatMany drug and alcohol abusers engage in habitual substance abuse for no reason other than to numb the effects of other symptoms they’re trying to cope with that are caused by mental illness. A reported 37 percent of alcoholics also have at least one serious mental health disorder.[4] In addition, mental illness is present in 53 percent of drug addicts.[5] In many cases, the user cannot afford care for their illness or isn’t even aware that they have it. Some people just aren’t willing to accept their diagnosis or lose their way in the uphill battle with trial and error treatments to manage the difficult symptoms of disorders like bipolar disorder and depression.The Food and Drug Administration is headquartered in Montgomery and Prince Georges County in Maryland. Established on the 30th of June in 1906,[6] the FDA continues to promote an image of the quintessential government agency that strives for the success and health of its nation over a hundred years later.

What They Do

The FDA is “responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics and products that emit radiation.”[7] In addition, the Food and Drug Administration aids in making medications less expensive, safer to take, and more effective at what they do.[8] Furthermore, they oversee the production, advertising, and distributing of tobacco products as well to aid in safeguarding the health of the public and decreasing the occurrence of tobacco use by underage individuals.[9]

Drug Approval

In the United States, government approval is required for the manufacturing and sale of specific drugs, and the Food and Drug Administration is solely responsible for the regulation of both over-the-counter and non-prescription drugs.[10] The entire process can be quite lengthy depending upon what type of product is being screened, but it is overseen from start to finish by the Office of the Commissioner.[11] It takes about 12 years on average for a drug to go from its lab-tested state to a product on store shelves, and that only happens for about one in every 5,000 drugs.[12]

The approval process for a new drug can take anywhere from six months for a priority review to 10 months for a standard review.[13] There are four steps to gaining drug approval which are submitted to the FDA; they are:

  • Investigational New Drug
  • New Drug Application
  • Abbreviated New Drug Application
  • Biologic License Application[14]

While over-the-counter drugs do require FDA approval, the application guidelines for prescription drugs are separate from OTC approval methods. When a manufacturer produces an OTC drug that contains ingredients that the FDA has already approved, automatic approval is rendered for the new drug to be marketed.[15] In 2003, the FDA took about 16.9 months on average to review each of the drugs that the agency approved.[16]

Drug Approval Process

For prescription drugs, there must initially be a roughly 3.5-year period of preclinical testing before the application can even be submitted to the FDA.[17] Once this step and IND application listed above have been processed, and the FDA does not prove the drug to be ineffective, Phase I clinical trials will begin with FDA permission and oversight. This takes about a year to complete, followed by trials for Phase II and III — which take an average of five years combined — as long as their predecessors qualify.[18]

At this point, the New Drug Application is submitted and contains all of the data gathered in the years of testing and trials; the review period for this step has been shown to take an average of 2.5 years – sometimes more, sometimes less.[19] After this step, approval is rendered, and the drug can be marketed; sometimes there is a Phase IV Study period in which data is gathered on individuals using the drug post-approval.[20] On average, the FDA rejects about 10 to 15 percent of all drug applications it receives.[21]

Big Pharma

A common complaint by many Americans and citizens of other countries alike who find the US to be a bit greedy and distasteful is in regard to the plethora of drugs the FDA approves and churns out each year. In all reality, there are thousands of products that are never evaluated at all by the FDA in addition to those that are. A common misconception among many is that items labeled as being “not approved by the FDA” are unsafe or have been rejected by the Food and Drug Administration. This is entirely untrue though. Some reports estimate that a shocking 90 percent of all the drugs the FDA has approved over the past three decades haven’t proven to be any more effective for the patients they’re treating than drugs that were already in existence.[22]

Effectiveness of Drugs

Otherwise, a product that hasn’t been approved simply hasn’t been screened. A lot of people have faith in the FDA to keep them safe, and thus, they question why a manufacturer wouldn’t want their product to be screened. Often, it isn’t a case of sidestepping authority or trying to fool the public; the fact is, not all products are required to go through such screening. The Food and Drug Administration maintains a database of more than nine million adverse events reported by consumers since 1969, titled the FDA Adverse Event Reporting System.[23] In addition, the liability falls somewhat on the consumer’s end for being responsible for what they purchase, use, or consume.

Other worries the public has regarding the FDA is the agency’s limited concern over high levels of mercury found in more than large-4 columns of 55 popular processed foods and beverages.[24] The FDA’s neglect of Monsanto-related issues and artificial sweeteners like aspartame are also disheartening to Americans.[25] Additionally, a review of 159 FDA advisory committee meetings showed that at least one person was present who posed a financial conflict of interest at 92 percent of the meetings.[26] Of course, the biggest red flag is that pharmaceutical companies have been lining the pockets of the FDA for years now. As of 2008, user fees paid to the FDA by drug makers were expected to reach a grand total of $438 million, making up over 42 percent of all funds received by the Food and Drug Administration for drug regulation.[27]

Mistaken Approval

Over the years, not every drug that has achieved FDA approval was so deserving of it. For example, in 1999, Vioxx hit the pharmaceutical market as a saving grace for those suffering from dysmenorrhea, acute pain, or osteoarthritis, and it was approved within the six-month priority review timeframe due to having fewer side effects than existing treatment drugs.[28] Merck, the maker of Vioxx, pulled the drug from the market in 2004 when it was discovered through long-term clinical trials that the drug increased the occurrence of colon polyps in patients.[29] Unfortunately, drugs like Singulair, Levaquin, and others would follow suit in later years.[30]

FDA Approved

Summary Judgment

Overall, the FDA seems to handle a large portion of their duties the way they’re supposed to. While there have been hiccups over the years, they aren’t frequent. In 2010, 16,500 people lost their lives to prescription pain medications.[32] Does this mean those medications weren’t safe? Not necessarily. It often means they weren’t used properly. The issues the FDA is up against are never black and white. While there are certainly cases in which some drugs were approved in error or without enough scrutiny, there are many more cases that have been handled correctly and approved with caution.

An approximate 106,000 deaths are due to adverse drug reactions every year in America.[31] In some cases, the manufacturer and FDA could both certainly be at fault. While the FDA claims to adhere to such tough scrutiny of the products they screen, how can errors like these be explained? The image of the Food and Drug Administration has come under fire on more than one occasion, as any government agency presumably has. When the public relies on a trusted source for safety precautions geared toward their own health, and their family’s health, lapses in that judgment often cause an uproar, because consumers simply don’t know whom to believe. The big pharma conspiracies grow every day and add to the discouragement the public feels about having faith in America’s government.

Treatment for Prescription Drug Addiction

Battling an addiction to over-the-counter or prescription drugs that have been approved by the FDA might leave you feeling as though you’ve been duped. You’re not alone. In fact, many are of the opinion that if a qualified physician is willing to prescribe a drug, then surely it must be safe. Likewise, why would a company manufacture anything that could harm its consumers? In short, because they weigh the risk and the potential profits and decide that any amount of money they could end up paying out in the occasional lawsuit is far less than what they could make from the sales of their drug overall.

At Rehab International, we can help those who suffer from drug addiction. All you have to do is pick up the phone and call us today. Our admissions coordinators are available now to help connect you with the right treatment program for you.



[1]Prescription Drug Overdose in the United States: Fact Sheet.” (n.d.). Centers for Disease Control and Prevention. Accessed September 8, 2014.

[2]Alcohol Use.” (n.d.). Centers for Disease Control and Prevention. Accessed September 8, 2014.

[3] Mayo Clinic Staff. “Drug Addiction: Risk Factors.” (n.d.). Mayo Clinic. Accessed September 8, 2014.

[4]Substance Abuse and Co-occurring Disorders.” (n.d.). National Alliance on Mental Illness. Accessed September 8, 2014.

[5] Ibid.

[6]FDA History – Part I: The 1906 Food and Drugs Act and Its Enforcement.” (2009 June 18). U.S. Food and Drug Administration. Accessed September 8, 2014.

[7]About FDA: What We Do.” (2014 August 5). U.S. Food and Drug Administration. Accessed September 8, 2014.

[8] Ibid.

[9] Ibid.

[10]About FDA: What Does FDA Regulate?” (2014 June 12). U.S. Food and Drug Administration. Accessed September 8, 2014.

[11]About FDA: About the Office of the Commissioner.” (2013 May 6). U.S. Food and Drug Administration. Accessed September 8, 2014.

[12]Drug Approvals – From Invention to Market … A 12 – Year Trip.” (1999 July 14). Medicine Net. Accessed September 8, 2014.

[13]Drugs: Frequently Asked Questions about the FDA Drug Approval Process.” (2011 November 14). U.S. Food and Drug Administration. Accessed September 8, 2014.

[14] Ibid.

[15] Ibid.

[16] John Hopkins Medicine. (n.d.). “What happens during the FDA review and approval process of drugs?ShareCare. Accessed September 8, 2014.

[17]Drug Approvals – From Invention to Market … A 12 – Year Trip.” (1999 July 14). Medicine Net. Accessed September 8, 2014.

[18] Ibid.

[19] Ibid.

[20] Ibid.

[21] John Hopkins Medicine. (n.d.). “What happens during the FDA review and approval process of drugs?ShareCare. Accessed September 8, 2014.

[22] LaMattina, J. (2013 July 30). “Are 90% Of FDA Drugs Approved In Last 30 Years No More Effective Than Existing Drugs?Forbes Magazine. Accessed September 8, 2014.

[23]Drugs: FDA Adverse Event Reporting System (FAERS) Statistics.” (2014 August 6). U.S. Food and Drug Administration. Accessed September 8, 2014.

[24] Gucciardi, A. (2012 February 10). “4 Proofs The FDA Does Not Care About Your Health.Natural Society.

[25] Ibid.

[26] Ellison, S. (n.d.). “Two Reasons Not To Trust The FDA.The People’s Chemist. Accessed September 8, 2014.

[27] Reinberg, S. (March 23). “Debate Builds Over Drug Companies’ Fees to FDA.ABC News. Accessed September 8, 2014.

[28] Kweder, S. (2004 November 18). “News & Events: Vioxx and Drug Safety.U.S. Food and Drug Administration. Accessed September 8, 2014.

[29] Ibid.

[30] Rosenberg, M. (2014 January 15). “6 Drugs Whose Dangerous Risks Were Buried So Big Pharma Could Make Money.AlterNet. Accessed September 8, 2014.

[31]The FDA Exposed.” (n.d.). Mercola. Accessed September 8, 2014.

[32]Prescription Drug Overdose.” (n.d.). NationalConference of State Legislatures. Accessed September 8, 2014


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