Financial Associated Press, February 19 (Editor Zhao Hao) U.S. Food and Drug Administration (FDA) Commissioner Marty Makary recently stated that unless drugs pose safety risks, are addictive or require medical monitoring, "all drugs should be converted to over-the-counter (OTC) sales."
On Wednesday (February 18) local time, Macari said in an interview that the FDA plans to make adjustments this year to allow more companies to switch prescription drugs to over-the-counter sales. He noted that the FDA is updating OTC monographs — the rule book that determines which drugs can be sold without a prescription — through “appropriate regulatory processes.”
Macari mentioned that the FDA is evaluating some "basic, safe" prescription drugs, such as antiemetics. "In my opinion, all drugs should be over-the-counter unless it is unsafe, requires laboratory testing to monitor body reactions, may be used for inappropriate purposes, or is addictive."
He added: "If a drug doesn't meet these conditions, why can't it be OTC? We should be asking 'why not' instead of saying 'you want to go OTC? There's a long and cumbersome process.'"
The FDA has long been considering changing some prescription drugs to OTC to improve drug accessibility, reduce medical costs, and help patients take their medications more consistently. For example, patients don’t need to take time off work to see a doctor for a prescription and can refill their medication faster.
Makary described the OTC expansion plan as another way to lower drug prices. He believes that putting drugs directly on shelves can bypass the system of middlemen such as insurance companies and "Pharmaceutical Benefit Managers" (PBMs), which are driven by rebates.
He said that OTC sales can increase transparency and "help to drive down prices." In some cases, due to "money games behind the pharmacy counter," the cash price of OTC drugs is lower than the patient's deductible for prescription drugs because employers and insurance companies share part of the cost.
However, the pharmaceutical industry does not fully agree with this proposition. Because most OTC drugs are not covered by insurance reimbursement, their prices may be higher than generic prescription drugs, which in turn puts a heavier burden on patients who rely on insurance.
Earlier this month, the Association for Accessible Medicines (AAM), which represents the generic drug industry, argued in a submission to the FDA that "converting a large number of prescription drugs to over-the-counter options may actually increase patient costs and thereby reduce access."
The Pharmaceutical Research and Manufacturers of America (PhRMA) also emphasized in its opinion that the FDA must abide by the core principle that "pricing factors must not influence regulatory decisions." PhRMA also stated that the FDA should not promote the direct conversion of prescription drugs to OTC without full consultation with manufacturers.
At the same time, AstraZeneca pointed out that several attempts in the past to change cholesterol-lowering statins to OTC sales have been unsuccessful, and "consumers have always struggled to make the correct self-choice."
In this regard, Makary said: "We have to trust people to make their own decisions and we have to get rid of this kind of paternalistic thinking."
(Zhao Hao, Financial Associated Press)
