FDA Considers Waiving Prescription Requirement for Key Drugs

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It seems as if there is a drug for pretty much every ailment. But drugs for diseases that should be addressed sooner rather than later, such as diabetes, tend to be prescription-only, a requirement that can stand in the way of timely treatment and one reason the Food and Drug Administration is weighing whether to eventually make the drugs available over-the-counter.

“These are discussions that need to start happening as we think about people’s health needs and how to improve access,” Dr. Margaret Hamburg, an FDA commissioner, told reporters this week.

Should the FDA lift prescription requirements for key drugs for conditions such as diabetes and asthma, patients would, in some cases, have to see a doctor only for an initial prescription, according to an industry-backed proposal. On return visits to the pharmacy, patients would use electronic questionnaires, diagnostic devices such as blood pressure monitors, and other computer-assisted technology to guide them in their medication protocols, a recent Associated Press story notes.

Although the FDA’s mandate is to ensure the safety and effectiveness of medications, it has shifted the status of several drugs from prescription to over-the-counter, including Prilosec, a version of AstraZeneca’s (NYSE:AZN) heartburn drug Nexium. And there has been a push in recent years to speed up the approval process for drugs and to find ways to encourage development in the industry.

Under the proposal being considered by the FDA, the AP adds, drug makers would have to request a switch for each drug individually, and the agency would judge the safety of each proposal on a case-by-case basis.


Article printed from InvestorPlace Media, https://investorplace.com/2012/03/fda-considers-waiving-prescription-requirement-for-key-drugs-azn/.

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