Could An Effort To Expedite The Drug-Approval Process Cause More Harm Than Good?

By Pawan Grover

When President Barack Obama signed the $6.3 billion 21st Century Cures Act into law Dec. 13, he said it would “lead to better years and better lives for millions of Americans.”
The bipartisan legislation has several goals, including the expansion of medical research and speeding up approval of new drugs and medical devices.
Proponents cite the difficulty pharmaceutical companies often have getting drugs into the market, given the high cost of research and compliance with FDA regulations. But critics worry that easing those regulations could harm the public if unknown drug side effects and other long-term issues slip through the cracks.
 “The Cures legislation will significantly improve profit margins for pharmaceutical companies,” says Pawan Grover, M.D., (www.inovospine.net) a surgeon and patient advocate who has participated in FDA research. “It will cut the costs of getting drugs through the FDA approval process and improve the opportunities to introduce more brand-name drugs into the marketplace.
“But will it lower the high cost of medications for the people who need them? That’s the real hardship facing patients.”
Some of Grover’s concerns include:
• Over medication. No one seems to be talking about the damaging effect that over-medicating is having on Americans’ health. “We are a pill-popping nation,” he says. “But we still don’t know how many medications work, or the harm that might be caused when patients are on multiple medications.” Even without the Cures legislation, the U.S. is one of the fastest nations in approving drugs, but we struggle with oversight and follow-up. 

• The effect of prescription-drug advertisements. According to the U.S. Food & Drug Administration, the U.S. is one of the few places in the world to allow direct-to-consumer advertising of prescription drugs. Physicians have said ads encourage some patients to get more involved in their own health care – a good thing. But it can be a problem when patients push for a drug because a commercial made it sound like a sure cure, or if they go from one doctor to the next, gathering up multiple prescriptions.

Careless over-prescribing is at the very heart of the kind of drug abuse problem President Obama addressed at the signing ceremony. “This is already a threat to our health, even with the FDA process we have in place,” Grover says. 

• Uncertainty that consumers will benefit from cost savings. The government has provisions to lower the costs of drugs but does not take action to do so. This problem is exposed time and again, Grover says, most recently with the EpiPen fiasco, in which the price of a medicine designed to save people from life-threatening allergies went from $20 to $600 without warning. “Pharma will benefit financially from a streamlined process, but there’s nothing in the Cures legislation that says the cost savings will be passed down to consumers,” he says.
Medications have saved lives, and having some processes to expedite treatment for rare diseases and sick patients is not a bad thing, Grover says.
“However,” he adds, “we can make provisions for this without throwing the baby out with the bath water.”
About Pawan Grover, M.D.
Dr. Pawan Grover (www.inovospine.net) has more than 20 years of experience as a medical doctor. He has served as a medical correspondent for CNN, NBC, CBS and PBS. He is a graduate of the Rutgers University Robert Wood Johnson Medical School.

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