FDA Aims To Streamline Rules To Boost Development Of Biosimilar Drugs
According to the Food and Drug Administration, biologic medicines make up about 5% of prescriptions, yet they account for 51% of drug spending. Other FDA news is on a probe into rare-disease drug denials, flavored e-cigarettes, and more.
Reuters:
FDA Proposes To Ease Testing Rules To Speed Up Biosimilar Drug Development
The U.S. health regulator issued a draft guidance on Monday to help drugmakers develop cheaper versions of complex biologic medicines, aiming to lower the cost of treatments for diseases such as cancer and autoimmune disorders. Biologic medicines, made from living cells, are among the most expensive drugs on the market. While they make up about 5% of prescriptions, they account for 51% of drug spending, the U.S. Food and Drug Administration said. (3/9)
Bloomberg:
FDA Investigated Over Rare-Disease Drug Denials By Senator
A key US Republican senator said he’s launched an investigation into the Food and Drug Administration’s recent denials of treatments for rare diseases, adding political pressure on an agency that’s already in turmoil. Wisconsin Sen. Ron Johnson said he’s seeking the FDA’s written denials to drugmakers, known as complete response letters. He plans to write letters to the agency asking why it denied certain drugs. He said he’s also considering having top FDA officials, including Commissioner Marty Makary, testify before the Senate’s Permanent Subcommittee on Investigations that he chairs. (Langreth, Smith and Cohrs Zhang, 3/9)
Undark:
Why The FDA Is Embracing Old Math For New Drugs
Clinical trials for a new drug can take years to complete, and cost up to hundreds of millions of dollars. New draft guidance from the U.S. Food and Drug Administration aims to make that process faster and cheaper for some studies, by encouraging a tool called Bayesian statistics. The approach dates back more than 250 years, and proponents say its embrace by regulators is overdue, stalled at first by feuding camps of statisticians, then later by a lack of familiarity among trained professionals. (Talpos, 3/10)
More FDA news —
The New York Times:
F.D.A. Opens Door To More Flavored E-Cigarettes
The Food and Drug Administration said on Monday that it would open the door to e-cigarettes in flavors that it deems appealing to adults, shifting from the agency’s unsuccessful ban on fruit and candy-flavored versions that have continued to flood the market. The agency said in a document released on Monday that it would consider vapes in flavors such as mint, coffees, teas and spices, possibly like clove or cinnamon. The F.D.A. said it would continue to reject those offering sweet or fruity flavors that are more appealing to teenagers. (Jewett, 3/9)
Radiology Business:
FDA Clears Next-Gen Image Viewer From GE HealthCare That Grants Radiologists ‘Anywhere Access’
The U.S. Food and Drug Administration has cleared a next-generation image viewer that grants radiologists “anywhere access” to scans, manufacturer GE HealthCare announced Monday. Leaders said the regulatory decision applies to GEHC’s View, a key piece of the Chicago-based company’s Genesis Radiology Workspace. The product is aimed at optimizing imaging workflows by letting radiologists work “virtually anywhere.” (Stempniak, 3/10)
