The FDA is often criticized for the amount of time it takes to test and approve a drug, a required step before a medication is able to be marketed and sold to the public. But behind the scenes, more and more pharmaceuticals are being quickly approved, bypassing the traditionally-required clinical trials that ensure a drug’s safety while providing the benefits they claim.
The Drug Approval Process
According to FDA.gov, the standard drug approval process is 3 phases:
- Phase 1: A drug must go through an initial small group study (20-80 participants) that evaluates the overall safety of the drug. Specifically, researchers are determining the proper dosage, possible side effects, and the metabolization time and location of the drug (kidney or liver).
- Phase 2: If the drug shows no major issues in Phase 1, then it undergoes a larger study (24-300 participants) that focuses on the efficacy of the drug. This time, researches are looking for short-term side effects and how effectively the drug treats the condition or disease it intends to treat.
- Phase 3: Phase 3 studies are more elaborate, involving anywhere from 200-3,000 participants. These studies gather more information about safety and effectiveness. Researchers look for drug interactions and if the drug has different effects on different participants.
What the FDA does not tell you on their website is that if there is a debate amongst the FDA’s scientific staff about whether or not to ultimately approve a drug, it undergoes an review in which an advisory panel votes ‘yes’ or ‘no’ to approve the drug. In many cases, the individuals voting are physicians with ties to the drug company and others who have had their travel and/or time compensated by the drug company.
In the late 70s, the average time before a drug received approval was just shy of 3 years. By the early 90s, with legislative efforts made to slash the long wait time, the FDA set a goal of a year for drug approvals. In 1997, the goal became 10 months. But how did the FDA cut nearly 2 years off their approval time between 1979 and the early 90s?
Drug Companies Funding the FDA
In 1992, Congress passed the Prescription Drug User Fee Act, a law that requires drug manufacturers to pay millions in application and “program” fees to cover the costs of trials associated with their drugs. The act is renewed every 5 years, and by the time it was renewed in 1997, the drug approval process was at an all time low of 10 months.
As of September 2017, the application fee for drugs requiring clinical data is $2,421,495. The application fee for drugs not requiring clinical data is $1,210,748. Program fees are $304,162.
Program fees are a one-time supplemental fee charged to the drug company during any fiscal year in which they submitted a pharmaceutical for FDA approval. The FDA describes this fee as necessary for covering staff and other costs associated with the ever-increasing number of drugs submitted to the FDA for approval each year. A company pays the program fee for each formulation it submits in a fiscal year, up to 5 drugs.
A recent investigation by ProPublica uncovered that 75% of the costs of testing drugs is paid for by the drug companies themselves.
Whether the FDA wants to admit it or not, former FDA employees and other pharmaceutical experts argue that this is conflict of interest. How can the companies who pay to keep the FDA afloat not have influence over the very people tasked with approving their drugs? One industry expert told ProPublica that not being “pro-industry” will not get you promoted at the FDA.
Drugs Receiving Quick Approval
There are other, quicker ways a drug can be approved, bypassing the traditional multi-phasic process. The four quicker pathways to approval are
- Accelerated approval
- Fast Track
- Breakthrough Therapy (drugs with this classification can also be applicable for Fast Track)
- Priority Review (targeted approval time of 6 months vs. 10 months)
All four classifications are intended for drugs that either show more promise in treating conditions than other existing treatments (if any) and for which there is a significant need. Fast Track, Breakthrough Therapy, and Priority Review designations all must be requested by the drug company.
The number of drugs receiving quicker approval under one of these designations continues to increase. Experts have found that nearly 70% of drugs classified as novel drugs received this designation from 2014-2016. Novel drugs are those that contain exact formulations not yet seen in other drugs.
While at face value, drugs coming to market more quickly seems to be a win-win situation, what’s lurking behind these rapid approvals is a scary fact. A study in the Journal of American Medical Association (JAMA) found that nearly 110,000 people die every year from drugs that were approved by the FDA. That’s more than twice as many deaths from breast cancer.
Defenders of the drug industry often point out that many drugs hit the market before lengthy studies are concluded, a plus for those whom have received life-saving drugs quickly. But the downside is grave: Many of these drugs overpromise on what they can deliver, causing serious injury or death.
The JAMA study also found that 1/3 of drugs with serious side effects only received a label warning of these issues AFTER FDA approval.
Time For a Change
There is no perfect process for approving drugs. Some side effects aren’t known for years after the fact. For those whom are suffering without a drug therapy, new and innovative medications that show promise are potentially their only shot at living with a condition or living at all. Long wait times for a drug to receive FDA approval when a patient’s life is on the line seems tortuous. There needs to be a balance between timely, adequate testing for safety and efficacy before approval, without interference from the very companies standing to make billions.
While more money facilitates quicker approval times, the question still remains: how long is long enough to truly evaluate a drug and its side effects? We don’t have the answer for that, but we do know that allowing drug companies to pay most of the costs associated with drug approvals feels fundamentally wrong.
If you or someone you love have suffered from dangerous side effects of a drug, the Chicago personal injury attorneys of Levin & Perconti can help. Many well-known drugs have been the focus of lawsuits against major drug manufacturers, often for marketing the drug for uses not approved by the FDA or for failing to pull a drug from the market, even when users have reported serious side effects.
Contact us now for a FREE consultation (312) 332-2872 or by completing our online case evaluation form.