During Wednesday (April 26)'s oral arguments in a highly watched U.S. Supreme Court case, a key government attorney shot down an idea from Supreme Court Associate Justice Stephen Breyer that FDA should weigh in through notice-and-comment rulemaking on how to interpret the biosimilar pathway before the court interprets the statute, given the complexity of the topic. The attorney assured the court that FDA has in the past declined to engage in rulemaking on this topic after being petitioned. Sandoz's council also argued Congress did not give FDA this authority, and drew sharp distinctions between the biosimilar law and the generic pathway, which they argued more closely involves FDA.
House and Senate lawmakers are discussing ways to attach to FDA user fee legislation a newly reintroduced bill that would prevent brand drug makers from using Risk Evaluation and Mitigation Strategies to delay generics, a Democratic lobbyist tells Inside Health Policy. But the effort could face hurdles: The bipartisan Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act was reintroduced Thursday (April 27) as a separate group of lawmakers, which includes the House Energy & Commerce chairman, push a competing REMS bill.
FDA Commissioner-nominee Scott Gottlieb said he is open to using new regulatory tools to demonstrate the agency's gold standard of safety and efficacy, and took a muted tone towards President Donald Trump's proposal to reopen FDA's negotiated user fee agreements and the administration's support for Right to Try legislation in his answers to more than 60 written questions from Senate health committee ranking Democrat Patty Murray (WA).
Scott Gottlieb laid out specifically how he would help combat the opioid epidemic if confirmed to FDA's top post, including using tools beyond the current Risk Evaluation and Mitigation Strategies (REMS), focusing on better labeling of abuse-deterrent products, collaborating with other federal agencies and setting out guidelines for when to get advisory committee advice. He set out his plans in responses to questions from Senate health committee ranking Democrat Patty Murray (WA), dated April 5. Gottlieb also said he would use the commissioner spot to support development of non-opioid analgesic alternatives for physicians and patients.
The Trump administration plans to delay implementation of the nationwide menu labeling rule that was set to go into effect May 5, drawing harsh criticism from the top Democrats. FDA sent an interim final rule to the White House budget office Wednesday (April 26) that would delay the effect date of the Obamacare-driven rule, which restaurants had sought more time to implement and which FDA Commissioner-nominee Scott Gottlieb recently signaled to lawmakers he would try to revamp if confirmed.
Marathon Pharmaceuticals announced Thursday (April 20) that it is resigning from all of its trade association memberships, including the Pharmaceutical Research and Manufacturers of America, following closure of a deal to sell its Duchenne muscular dystrophy drug, Emflaza, which the company was accused of price gouging earlier this year. While Marathon's resignation letter, obtained by Inside Health Policy, cites the closure of the deal as the reason for leaving PhRMA, a drug pricing lobby group frequently critical of the brand industry claimed the departure was due to controversies over the company's pricing strategy. PhRMA announced it would reevaluate its membership criteria earlier this year in light of pricing controversies, and another company caught in drug pricing controversy left the trade group earlier this month.
A group of Democratic lawmakers is asking FDA Commissioner-nominee Scott Gottlieb to expand on how, if confirmed, he would ensure FDA is sufficiently staffed and funded, how a hiring freeze would affect his ability to lead the agency and how he would implement hiring provisions under 21st Century Cures. A spokesperson for FDA confirmed to Inside Health Policy that the agency has yet to receive its funding from Cures, which contains provisions aimed at making it easier for FDA to recruit new personnel.
The issue of how to create a framework to address cybersecurity regulatory science gaps will be discussed at a public workshop next month held by FDA, National Science Foundation and Department of Homeland Security's Science and Technology Directorate, coming as FDA's device center pegs cybersecurity as one of its top 10 regulatory science gaps. The framework is expected to include collaborative research by the three parties as well as academia, the medical device industry and third-party experts with input from FDA.
Senate health committee Chair Lamar Alexander (R-TN) and ranking member Patty Murray (D-WA) have introduced omnibus FDA user fee legislation, which is unchanged from the discussion draft released April 14, according to a spokesperson for Alexander.
Pharmaceutical investors in India report that compliance with FDA regulations is their top concern, coming as the agency increases its inspection focus on India after having reached a pharmaceutical pact with the EU. India is the second largest supplier of pharmaceuticals and biologics to the United States, but quality issues are an ongoing challenge for India's drug industry, according to FDA.
The U.S. Supreme Court heard oral arguments Wednesday (April 26) in Amgen v. Sandoz -- the high court's first case dealing with the biosimilar pathway established by the Affordable Care Act and which stakeholders view as key to determining the rules of the road for innovator and biosimilar sponsors. While some see the potential for the case to have wide-reaching and potentially detrimental effects, others see it as likely the first of many cases that will shape the evolving market.
FDA announced Friday (April 21) approval of Samsung Bioepsis Co LTD's biosimilar for Remicade, which appears to be the first biosimilar approved without an advisory committee weighing in, as well as the first biologic product to follow FDA's biologic naming scheme after the agency finalized the convention in January.
The California drug lobby takes strong issue with drug pricing transparency legislation approved overwhelmingly by the state senate's health committee Wednesday, arguing the bill is counterproductive because it focuses on list prices and doesn't factor in the roles of pharmaceutical benefit mangers (PBMs) and insurer. State Sen. Ed Hernandez's (D) price transparency now heads to the California senate's appropriations committee.
The White House budget office met with federal agencies Friday (April 21) to prepare for a possible government shutdown should Congress not pass a new spending bill when the Continuing Resolution expires in a week. The Office of Management and Budget told agencies the contingency plans they updated last December when a similar shutdown loomed are likely sufficient and stressed it doesn't anticipate an actual shutdown.
House Energy & Commerce health subcommittee Chair Michael Burgess (R-TX) signaled Tuesday he would seek to attach four bipartisan medical device bills to the FDA Reauthorization Act of 2017. The bills would allow over-the-counter marketing of hearing aids, require registration of medical device servicers, lay out a medical imaging approval process whereby contrast agent sponsors could submit supplemental applications, and set up a risk-based device inspection system and ease the export certificate process.
The Senate health committee voted 14-9 to approve Scott Gottlieb's nomination to be FDA chief despite continued concerns from ranking Democrat Patty Murray (WA) about his potential financial conflicts of interest and industry ties. Murray and eight other Democrats voted against Gottlieb, but Democrats Sheldon Whitehouse (RI) and Michael Bennet (CO) broke with their party to vote for the nominee.
Republican leaders of a key House health committee asked HHS Secretary Tom Price why the agency seemingly broke its promise to issue an updated Pandemic Influenza Plan in late 2016, asking for a response in less than two weeks on the status of the updated plan.
Senate Democrats are questioning FDA Commissioner-nominee Scott Gottlieb about his ties to fentanyl manufacturer Cephalon, both before and after he worked at FDA as deputy commissioner. The questions follow reports that Gottlieb played a role in trying to help Cephalon secure more of the addictive opioid fentanyl to manufacture its products. Lawmakers request that Gottlieb respond to questions about his connections to Cephalon by Friday (April 28). The letter was sent shortly after the Senate health committee approved Gottlieb's nomination.