QUICK READ: In a major development, a Japanese pharmaceutical company has started the final stages of human trial for its antiviral flu drug to treat COVID-19. But will their clinical trials meet the criteria for new drug approval for the FDA if successful?
New drug development and approval haven’t changed in a lot of ways. Maybe it’s time to look at the whole process and cut the fat but to do so without endangering patients is going to be a challenge.
In order for new drugs to be approved the FDA needs data, lot’s of data. Collecting that data and analyzing it takes precious time but when patients are in dire need time can be the enemy.
Some have called for a suspension of liability for hospitals and doctors who are treating Coronavirus patients. This could be a good step but what about the use of unauthorized treatments that can cause death?
Every day on TV there are ads for lawyers who want patients to join litigation lawsuits against Pharma companies. The problem is that most people who join these lawsuits get pennies compared to the law firm who usually gets a ton of money.
There can be no excuse for misleading the FDA with only part of the data but the truth is we don’t know the one-term effects of using certain prescription drugs. FDA approval is based on evidence — provided by the company that makes the medical product — that the benefits of the product outweigh the risks for most patients for a specific use. It doesn’t necessarily mean the product is safe.
Even though data from human trials are analyzed by a team of experts before a drug is approved, it can be impossible to anticipate all bad reactions — especially very rare safety risks.
Now some patients may be willing to take those risks but they have to fully understand the risks and we’re not sure they do even when they sign agreements. The truth is that ALL prescription drugs have side effects and some may not appear for years after the drug is approved.
Even with all this, I believe there are ways in which we can speed drugs to market by cutting government processes. To date, no FDA commissioner has tackled the way the FDA approves drugs or regulates DTC. It’s needed very badly.
We all want a “cure” for COVID-19 but the cure can’t be worse than the disease and cause more harm to patients. Hopefully, the review processes will look at the data very carefully before making a decision that could further endanger lives.