My Thoughts on the FDA Approving Drugs at a Faster Pace
I was reading the news online when something caught my eye immediately. I couldn’t believe it. On Bloomberg.com there was an article stating that drugs are being accepted by the FDA very fast, which is raising alarms and concerns among the consumer advocates.
“The medications are being approved so quickly that pharmaceutical companies are now preparing for a green light months in advance of the scheduled decision date, a pace that’s helping patients with rare or untreatable diseases.”
As a “professional patient,” this raised concerns for me. How long did it actually take for the potential medication to go through the proper channels? Do the benefits outweigh the serious risks? If there are serious risks, why not go back to the drawing board and develop something that has fewer side effects that isn’t as harmful?
I did some research and found what the normal process for a pharmaceutical company to get their product approved is. Companies have to do the following:
Step 1. — Discovery and Development
Step 2. — Conduct Preclinical Testing
Step 3. — Clinical Research
Step 4. — Get approval for a clinical trial from a local Institutional Review Board
Step 5. — Conduct the clinical trials
Step 6. — Submit a New Drug Application
Then companies can begin promoting it to the public and medical community.
I’m sure there will be questions from many outside sources including the media, doctors, hospitals, and some people about the FDA’s decision to fast track these approvals. Who will be responsible for the cost once the item is on the market? Will the insurance cover it or will it be the patient’s responsibility? What is the physician’s honest opinion about the fast approved drug? How much does he know about it and would he recommend it?
If patients have concerns before considering a new treatment, the drug manufacturer needs to be accessible via the internet with contact information including a phone number so if a person has questions, they can actually talk to someone who is very familiar with the fast track process.
I believe that the more information that is available to the consumer, the better they will be able to make educated decisions.
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