HomedrugsOn Medication – FDA Drug Approval Process and Exceptions

In America, every drug must be approved by the FDA, or the Food and Drug Administration, before going on the market.

How Drugs Are Approved
Before medication makes it to the physician’s prescription pad, and eventually into your child or you, it must first go through a required set of steps regulated by the FDA.

  1. Investigational New Drug Application (IND) submitted by sponsors (drug companies, research labs, etc). Contains results of animal testing, and plans for human testing. FDA uses that to determine whether or not to continue the process.
  2. Approval of upcoming testing conditions – people who can take part, how many will be needed, testing schedule, medication dosages, consent procedures, etc.
  3. Around 20 to 80 healthy volunteers take the drug to determine what kind of side effects there are. This is known as Phase 1 studies. If toxicity levels are low enough, the drug goes on to the next step, also known as Phase 2 studies.
  4. Around 48 to 300 volunteers suffering from the condition for which the drug is intended are divided into groups, and one group is given the drug. This is how the initial effectiveness is determined. They’re also monitored for continuing side effects.
  5. If both the FDA and sponsors agree with the effectiveness of Phase 2 studies, Phase 3 will begin. These studies involve several hundred to about 3,000 subjects, and numerous variables are tested, such as drug interactions, and varying genders/ethnicities/ages.
  6. After FDA has approved the product for marketing, labeling requirements and additional commitment studies are carried out. These final studies don’t take place for all drugs, but when they do, they continue to measure effectiveness and safety of the drugs.
  7. Sponsors file the NDA, or New Drug Application. It contains all study data throughout the process, how it’s manufactured and how it works. This form must be approved before the drug can be legally marketed.
  8. FDA must decide whether or not to file this form within 60 days before renewal. During that time, they check to make sure the form is complete and all studies are present. If there’s something wrong, the form can be rejected.
  9. Once filed, the drug may or may not be approved. The FDA aims to address priority drugs within 6 months, but around 90% of the forms are reviewed and acted on within 10 months.
  10. FDA reviews labeling, and makes sure proper information is communicated to doctors and consumers.
  11. FDA inspects drug processing facilities.

Phew. That’s lengthy, isn’t it?

This process can take years, especially the testing aspect. However, if a new drug is desperately needed for a horrible disease, like AIDS back in the ’80s and ’90s, and Ebola now, it can be enrolled in an accelerated program, which relies on things like blood tests and x-rays instead of actual clinical trials.

Naturally, problems are more likely to arise in the general population after the accelerated program, but in cases of emergency, that risk may be worth it. However, those risks are why so much testing is done in the first place for most other medications.

Hubby’s invite to take part in an asthma drug study.
Whoever sold our information didn’t realize that I’m the one
with asthma, not my husband.

Legal Gaps in Testing
There are two groups of drugs that are sometimes prescribed without making it all the way through the FDA approval process.

Investigational drugs are also sometimes used when the patient isn’t responding to any of the approved drugs, and their condition must be treated. These are drugs that haven’t made it all the way through the approval process, yet, but are currently being tested.

Off label usage is also relatively common. This is when a drug is prescribed at a different dosage, administered differently or is treating a different condition than what it’s FDA approved for. These drugs are usually identified for off-label usage through medical testing, or even by accident. Sometimes, these drugs are later submitted for FDA approval, but that’s not always the case.

This can be problematic, especially when drug companies use an approval for one type disease as a blanket approval for advertising purposes. There have been many incidences of this activity, but I’ve included two in the resources section below.

Because children comprise a smaller population in the medical market, and studies done on them are often lacking, which means the likelihood of kids experiencing more severe, previously unknown side effects, is higher. Medications for adults are still often prescribed on this basis for children who fall into assorted categories, including those on the autism spectrum, have ADHD or mental health issues. That said, there are subsets of the FDA dedicated to further study of medication’s effects on children.

Other populations, like women and people not of Caucasian lineage, also suffer similarly. The default test subject is still the white male, and studies often still revolve around that demographic. This causes problems in all areas, especially when it comes to how drugs interact with natural hormonal cycles, pregnancy and genetic predispositions unique to certain groups. The FDA is, at least, trying to address these internal problems with departments dedicated exclusively to each group. It may not seem to be much yet, but it’s a start.

There are, however more problems with the system in general, which I will go into in a later entry.

The FDA’s Drug Review Process: Ensuring Drugs are Safe and Effective
Understanding Investigational Drugs and Off Label Use of Approved DrugsDecember 12, 2012: Pfizer Agrees to Pay $55 Million for Illegally Promoting Protonix for Off-Label Use
February 28, 2011: Elan Pharmaceuticals Pleads Guilty, Sentenced for Off-Label Marketing of Zonegran
Pediatric Safety
Gender Studies in Product Development: Executive Summary
Clinical Trials Shed Light on Minority Health

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