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Americans could soon get cholesterol-lowering drugs and other widely used prescription drugs without consulting a doctor, which would be a first step toward radical changes in the way patients access treatments for chronic diseases.
In a draft directive on Tuesday, the US Drug Administration explained how such a statute, which, according to the agency, could help reduce health care costs, would work. Patients could answer questions about a mobile phone application to determine if they should be able to access a drug without a prescription.
"We hope that the steps we are taking to move this new, more modern framework forward will help reduce the costs of our overall health care system and increase the efficiency and empowerment of consumers by increasing availability of certain products that would otherwise be available only on prescription, "said Scott Gottlieb, FDA Commissioner, in a statement
. to help companies think about how they might seek approval for these drug sales. A new FDA regulation that would make the official path is expected next year. Gottlieb said this measure should not lower the bar for the transfer of prescription drugs to over-the-counter medications.
The goal of regulatory agencies in recent years is to find a way to expand access to prescription drugs. 19659002] The FDA explored the idea of an "over-the-counter" designation in 2007 that would have required interaction with a pharmacist. The Government Accountability Office in a 2009 report on the proposal asked if consumers ended up paying more for their medications since over-the-counter medications are usually not covered by insurance.
The idea resurfaced in 2012 reclbadify treatments for high blood pressure, cholesterol, migraine headaches and over-the-counter asthma. The market for these drugs is vast: according to Bloomberg Intelligence, global sales of cholesterol-lowering drugs totaled $ 7.33 billion last year.
EpiPen, Naloxone
Just over half of American adults, or about 43 million people. the need for cholesterol medications take it, according to the Centers for Disease Control and Prevention. About 75 million Americans, or one in three adults, have high blood pressure, although only half of them have the disease under control, according to the CDC.
GAO report suggests that drugs fight life Health-threatening allergies, such as EpiPen Mylan NV, could benefit from similar status over the counter. Gottlieb in his statement Tuesday also said that naloxone, the opioid-overdose antidote, could follow the proposed route. Naloxone is available without prescription in most states, although access has been reported to be limited.
Pharmaceutical companies should submit data to the FDA that shows that consumers are able to properly badess their drug needs and their ability to use "Our ultimate goal with the modernization of our regulatory framework for drugs in Canada." Free marketing is to facilitate a more competitive market, facilitate access to medical products, empower consumers in their health decisions and offer more affordable options. Americans, "said Gottlieb.
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