Safety of Newly FDA Approved Drugs
Drug Safety: Is it All Relative?
As a health care consumer, you want to be able to believe the information medical professionals tell us. You want to be to entrust your health and well-being to the health care providers you've chosen. There are numerous areas where that trust is paramount -- in diagnosis, treatment plans, therapies, surgeries and medications.
But what about those medications -- especially prescription medications? Are the drugs prescribed for the prevention and treatment of your condition safe? Will the medications cause more health problems than they relieve? And once a drug has received the U.S. Food and Drug Administration's approval, are you still a human guinea pig if you take the drug in its early years of its release?
Pharmacy 102: Drug Studies Who, What, When, Where and Why
FDA Approval Process Designed to Promote Drug safety and Efficacy
The FDA is charged by the federal government with ensuring that prescription medications both do what they claim to do and do so with relative safety.
Relative safety because all drugs, even those from natural sources, have the potential to cause side effects or adverse reactions.
Relative safety because sometimes difficult-to-treat or difficult-to-cure conditions require medications that have the potential to cause serious, sometimes even life-threatening side effects/adverse reactions, but the potential benefit to the recipient outweighs the risks.
Insights into Clinical Research in Drug Development
More Information on Medications, Drug Safety
- The Basics of Clinical Trials
A look into how clinical trials are designed. Including some examples of drugs that have an interesting history and unsafe drugs that were pulled off the market. Also cancer clinical trials are briefly discussed.
- Are Generic Drugs Equal to Brand Name Drugs?
- Drug Research: How a Drug Goes From the Test Tube to the Market
How a drug goes from the test tube stage to the pharmacy. Here's what happens to people who volunteer for research studies.
Simplified FDA Approval Process for New Drugs
The FDA provides an abbreviated version of the approval process for new drugs:
- Preclinical testing -- animal testing; if successful then,
- Sponsor of the proposed new medication completes an Investigational New Drug application, IND, that spells out what the sponsor proposes for human clinical testing. If the IND is approved then,
- Phase I clinical testing begins, usually involving 20 to 80 study participants. If all goes smoothly through this first level of human testing then,
- Phase II clinical testing begins, this time usually involving a few dozen to 300 study participants. If all goes smoothly through this phase of human testing, meaning the new drug formulation is proving successful in the treatment of the symptom or condition for which it is intended AND side effects/adverse reactions have been few, then
- Phase III clinical testing begins, this time involving several hundred to about 3,000 people. Again, if this testing phase goes well, then
- This is the pre-new drug application, NDA, period. It is at this time that the FDA and the drug's sponsor usually meet.
- Completion and submission of the NDA. This is the formal step in seeking the agency's approval to market the new drug.
- The FDA has 60 days to decide whether to review the NDA for filing
- If the FDA decides to file the NDA, a review team is assigned to evaluate the research data provided by the sponsor on safety and effectiveness of the proposed medication.
- The agency reviews the information provided by the drug sponsor as to the drug's professional labeling, that is, usage instructions.
- The proposed manufacturing site for the potential new drug is inspected by the FDA
- FDA reviewers will either approve the NDA or provide a complete response letter to the drug sponsor.
Each phase of testing may take from several months to multiple years.
To view this process in pictorial graphic, click here.
The Science Behind FDA Newly Approved Drugs
Bumps in the Road to FDA Drug Approval
The road to market for any prescription medicine from its inception in a laboratory to approval by the FDA can be fraught with speed bumps, potholes or dead-ends.
There is no guarantee that ideas born in the laboratory will ever make it beyond the test tubes and petri dishes to begin the journey of becoming a useful drug into animal studies. There are even fewer discoveries that succeed through the animal study portion of the steps toward becoming a marketable drug, and so it goes through each step of the process.
Research Shows Clinical Research Trials, FDA Approval Process Not Infalliable
An article published in the Drug Information Journal in 2004, authored by Elane M.Gutterman, PhD, revealed the limitations of even the three-phase clinical research trials in being able to reveal side effects/adverse reactions that occur with less frequency than 1/1000th because even with the use of a few thousand participants, there are just not enough people for those adverse events to necessarily occur during the research trials.
Another factor affecting the likelihood that "real-life" situations will all be represented within the pre-approval phases of testing is that study participants are often chosen without the presence of any chronic or acute illnesses beyond the one for which the proposed drug is designed to treat. In real-life, many of the patients receiving the newly-approved drug are likely to have more than one condition or diagnosis; in real-life people are also likely to be taking a different variety of prescription and over-the-counter medications that weren't represented during the clinical trials.
Protect Yourself Against Possible Drug Safety Concerns
Being pro-active in your health care is a great way to protect and arm yourself as an active participant in your health care, whether its about the medications you take or the diagnosis you're given. Read as much as you can about your medications, from the label on the drug bottle to the product insert to information you can find on the Internet.
Talk to your health care provider; talk to your pharmacist; talk to the nurses -- all of these people are resources for any questions or concerns you may have. If you don't get the answers you're seeking, consider getting a second opinion. You have a right to have your questions and concerns taken seriously by these health care professionals.
If you and your doctor determine that a newly FDA-approved drug is an appropriate treatment for your condition, be sure to notify your doctor at once if you begin to experience symptoms that may indicate medication side effects.
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