Like it or not, Donald Trump is now officially the President of the United States. One thing we are seeing from the White House is that he is making good on his campaign rhetoric. With that in mind, there is one statement he made on the campaign trail that will likely affect the approval process for prescription drugs.
“There are over 4,000 drugs awaiting approval, and we especially want to speed the approval of life-saving medications,” writes the Washington Examiner, quoting Trump from an October 2016 campaign speech.
Do We Need to Speed Up the Process
Currently, a drug can take ten years to receive full approval by the U.S. Food and Drug Administration (FDA). However, this is not a hard-fast rule for approval. Each drug must take a unique path to approval and could find itself on the market much quicker.
An article by John LaMattina in Forbes sums up both sides of the approval process argument:
“The FDA is America’s gatekeeper for access to new drugs,” writes LaMattina. “As such, it gets a lot of scrutiny from the press, Congress, and generally anyone with a major stake in the decisions it makes. There are those who claim that the FDA is too lenient in its decision making process and that it unleashes unproven new drugs on an unsuspecting public that presumes any medicine approved is safe and efficacious. Others will assail the FDA as being far too conservative and say that the agency is unnecessarily delaying access to new life-saving drugs because of its bureaucracy.
Regardless of your views, you’ll likely get a chance to voice your opinion if the Trump Administration decides to move forward with any change.
Right-To-Try Laws
While there will be heavy debate between the FDA and the Administration, this brings up “right-to-try” laws which could be part of the overall “approval” process.
For those not familiar, right-to-try laws are issued by states, allowing patients with terminally ill diseases to use experimental drugs and therapies that have not been approved by the FDA. Some people believe this helps show the viability of a drug which could speed up its approval process. Others argue it is even more dangerous because there is no data showing efficacy of the drug being used.
Regardless, speeding up the approval process by the FDA is sure to shake up the right-to-try debate. Data obtained from right-to-try use could become part of the overall approval process and also free up other states to implement such laws (like California recently did in 2016).
Faster Approval Still Doesn’t Cover All Pharmaceuticals
One thing to keep in mind is that the FDA approval process does not cover over the counter medications and products. That is why there will still be litigation against manufacturers of these products, similar to Johnson and Johnson who is dealing with a wave of lawsuits involving talcum powder and ovarian cancer.
So, no matter what side of the debate you are on, doing anything with the approval process will not protect or harm anyone from certain drugs. While baby powder is certainly one example, you can also include the many nutritional supplements that do not come under the jurisdiction of the FDA.
Final Word
Regardless of your like (or dislike) for Trump, one thing is for sure. He will likely shake up the FDA approval process sometime during his presidency. I cannot tell you the likely outcome, but I will predict it will be a fight from everyone with a stake in the issue.