Senior Editor
There was good news for Americans on the generic drug front amid the pandemic in 2020, according to a report from Sally Choe, director of the Office of Generic Drugs, Center for Drugs Evaluation and Research.
Choe noted that there are more than 10,000 FDA approved generic drugs and nine out of 10 prescriptions in the United States are filled by generics. Generic drugs have saved the health care system close to $2.2 trillion dollars in the past decade.
Amid the challenges of a worldwide pandemic and rapidly advancing science, the FDAâs generic drug program continued steadfast efforts to help increase the availability of safe, effective, high-quality, more affordable drugs in the United States, Choe said.
Senior Editor
The Association for Accessible Medicinesâs new economic analysis has found that delays in the approval of complex generics are costing the U.S. health care system an estimated $1.3 billion each year.
The analysis, titled âPotential Savings from Accelerating US Approval of Complex Generics,â was sponsored by Teva, and unveiled at an event, hosted by The Hill and sponsored by AAM, discussing the role of complex generics in the prescription landscape.
Complex generics, including epinephrine auto-injectors for anaphylaxis and inhalers used to manage asthma, treat chronic and serious medical conditions, such as multiple sclerosis, schizophrenia, metastatic breast cancer and diabetes.
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Last week, on December 29, 2020, the Food and Drug Administration (“FDA”) published a notice setting the amount of new annual facility fees for both for over-the-counter (“OTC”) monograph drug product manufacturers and for OTC monograph drug product contract manufacturing organizations (“CMOs”). The annual facility fee for OTC monograph drug manufacturers – the so-called Monograph Drug Facility (“MDF”) fee – was set at $14,060,[i] and the annual facility fee for CMOs was set at $9,373.[ii] According to the notice, for FY 2021, facility fees would have come due February 12, 2021.[iii]
However, just two days later, on December 31, 2020, the Department of Health and Human Services (“HHS”) withdrew the FDA notice and directed FDA to cease enforcement of the OTC user fees[iv] at least for the time being. HHS’ action responded to criticism that fees would apply to OTC hand sanitizer manufacturers ope
Today, the U.S. Food and Drug Administration approved the first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit, for the treatment of severe hypoglycemia (very low blood sugar), which may occur in patients with diabetes mellitus.