A core drug substance and a four-letter alphabet soup suffix: that's the FDA's proposal for nonproprietary, or "proper," names for reference biologics and biosimilars. But the agency is still on the fence about naming interchangeables. Should they, like biosimilars, be distinct? Or should they share the core and suffix of the reference product? The FDA wants to know what others think and is requesting industry feedback. The draft guidance and proposed rule were published in Friday's Federal Register. Comments are due by Oct. 27 on the guidance and by Nov. 11 on the rule.
The FDA needs to apply the brakes on its headlong rush to adopt quality metrics for the manufacturing of drugs. That was the view of industry groups speaking at a public meeting last week on a draft quality metrics guidance released last month. All were unanimous in urging the FDA to "start small, learn and revise" before dashing into a full-blown metrics program that could drive drugmakers and the agency itself into a sinkhole of data with no clear methodology for how it would be used. Before issuing a final guidance, the FDA should provide more of everything, various industry groups said, including more time for comments, more definitions, more transparency, more clarity and more consideration for the burden specific metric requests would impose on drugmakers.
The Patent and Trademark Office is seeking comments on a proposed pilot program that would change how post-grant administrative trials are instituted and conducted in the U.S. Currently, a panel of three administrative patent judges (APJ) decide whether a trial is warranted for inter partes review, post-grant review or covered business method review petitions. Then the same panel conducts the trial. Under the proposed pilot, one APJ would make the decision to hold a trial and would then be joined by two other APJs in conducting the trial. Comments on the proposal are due by Oct. 26.
MDUFA and PDUFA received scathing grades for their unintended consequences and negative impact on drug and device innovation. Overall, the five-year agreements scored a -3, on a scale of -10 to +10, according to a Medical Innovation Impact Index alert issued by the Initiative for Patient-Centered Innovation at Fairleigh Dickinson University. While the prescription drug and medical device user fee agreements have provided additional resources for the FDA and aimed for shorter review times over the years, the alert pointed out that they've created a "disjointed, cumbersome and exploding body of law" that's actually hampering reviews and discouraging innovation.