FDA has put on hold until next March a controversial tobacco "intended use" rule that sparked controversy due to a last-minute addition that industry said posed extensive liability issues for drug and device manufacturers. Key industry groups petitioned the agency last month to put the rule on ice, and FDA said Friday (March 17) that the regulation, originally slated to go into effect Feb. 8 and pushed back to March 21 due to the regulatory freeze, has now been delayed to March 19, 2018.
The House is unlikely to honor President Donald Trump's budget request to double user fees, a House GOP aide told Inside Health Policy Wednesday (March 22), emphasizing that key committees have already began considering the user fee commitments agreed upon between FDA and industry. However, one key Democratic lawmaker was concerned by what they saw as indications that FDA might support reopening the agreements.
Four former FDA commissioners on Thursday (March 16) urged Congress not to move forward with drug importation, which has been eyed by both President Donald Trump and members of Congress as a drug pricing solution, on the grounds that allowing drug imports would pose safety risks, strain FDA resources and do little to bring down costs. Trump's pick to head FDA also previously said the amount of agency oversight needed to prevent entry of fake drugs would zero out any cost-savings from imports.
Recent calls from the medical device industry for Congress to push a risk-based framework for regulating laboratory developed tests (LDTs) appear to be answered by a new bipartisan draft bill that would give FDA authority over design, development, validation and production of in-vitro clinical tests (IVCTs), including LDTs, while retaining CMS' jurisdiction over laboratory operations. The program would also grandfather in already marketed IVCTs, give FDA recall authority over certain tests, and set up new center at FDA for regulating the tests, coupled with a user fee program.
With a new White House keen on controlling rising prescription drug costs, compounders say it is time to consider allowing certain pharmacies to compound high-priced generic drugs that are economically unavailable to patients. But a look at FDA nominee Scott Gottlieb's past statements on compounding appear to suggest he would not be open to the idea.
The House oversight committee held a hearing Wednesday (March 22) on the impact of voluntary restricted distribution systems -- programs the Association For Accessible Medicines say "mimic FDA [Risk Evaluation Mitigation Strategies] programs, or hide behind the veneer of patient safety and FDA mandates," but are used by brand companies to restrict access to samples for bioequivalence testing and delay generic competition. The move by the watchdog committee comes as lawmakers continue to point to generic competition as an answer to President Donald Trump's calls for lower drug prices, and lawmakers in both the House and Senate attempt to push through a bill that would incentive first generic development and mandate a study on REMS.
Despite a recent agreement between the United States and European Union (EU) allowing both parties to recognize each other's pharmaceutical good manufacturing practices (GMP) inspections, FDA will not take enforcement action against foreign manufacturing facilities that an EU inspectorate finds out of compliance without first looking at the case itself and perhaps even performing its own inspection, a spokesperson for the agency said.
One lawmaker touted the Research to Accelerate Cures and Equity (RACE) for Children Act during the House Energy & Commerce Committee's hearing Wednesday (March 22) on the Prescription Drug User Fee Act (PDUFA) reauthorization. However, FDA drug center chief Janet Woodcock declined the lawmaker's request to opine whether the bill would improve pediatric access to cancer drugs.
A key cancer research advocate warned lawmakers Wednesday (March 22) that the Trump administration's hiring freeze and recent proposed budget cuts to the National Institutes of Health (NIH) could have a serious impact on the future of FDA's recently launched Oncology Center of Excellence (OCE), and urged lawmakers to swiftly pass PDUFA VI as written.
A week after the president took stakeholders by surprise by proposing industry fully pay for FDA premarket reviews by doubling up on user fees, the White House plan was barely mentioned as Senate health committee Chairman Lamar Alexander (R-TN) launched hearings Tuesday (March 21) on user fee pacts penned by the Obama administration and industry. Alexander vowed to move expeditiously to reauthorize the expiring fees so that FDA wouldn't have to send layoff notices to employees in late July.
An international group of compounders is working with lawmakers to draft a new letter asking FDA to rescind guidance requiring a patient-specific prescription for each drug compounded under 503A, and return to the states' control over office-use compounding, saying the agency's prohibition on such compounding runs against congressional intent. The call to rescind the guidance comes less than a week after President Donald Trump ordered agency heads to improve efficiency by shifting functions to state or local governments.
The House Energy & Commerce health subcommittee will hold a hearing next Tuesday (March 28) on reauthorization of the Medical Device User Fee Amendments (MDUFA), marking the committee's third user fee hearing. The panel held a hearing March 2 on reauthorization of the generic and biosimilar user fee agreements, and will hold a hearing Wednesday (March 22) on the Prescription Drug User Fee Act.
Senate health committee Chair Lamar Alexander (R-TN) announced Thursday (March 23) the committee will schedule a confirmation hearing for FDA commissioner-nominee Scott Gottlieb once it receives his paperwork from the Office of Government Ethics.
Marathon Pharmaceuticals is selling its controversial Duchenne muscular dystrophy drug, Emflaza, for $140 million, however it is unclear whether the company will drastically increase its profits by selling the priority review voucher it was rewarded for getting the drug approved. Key lawmakers have said Marathon gamed the PRV system, which is meant to incentivize research on rare diseases, and have asked the company to specify its plan for the voucher -- which could fetch hundreds of millions of dollars.
House lawmakers, FDA officials and industry stakeholders all praised the success of the agency's breakthrough designation in lowering drug development times, and stressed that the pending Prescription Drug User Fee Act (PDUFA) reauthorization will bring important resources to the breakthrough effort. The widespread commitment to the designation at a House hearing Wednesday (March 22) is likely to please FDA Commissioner-nominee Scott Gottlieb, who has proposed sweeping reforms to build upon the breakthrough program, which he has said speeds drug entry to market.
Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) reintroduced legislation Tuesday (March 21) to make certain hearing aids available over the counter, following calls from the Obama White House and the National Academics of Sciences, Engineering and Medicine for creation of such a category. FDA has also indicated it is seriously considering the idea of an OTC hearing aid, and recently loosened restrictions on dispensing hearing aides.
There are less than 20 pending generic applications for drugs currently without competition, FDA drug center chief Janet Woodcock told Senate health committee lawmakers Wednesday -- prompting a key Democrat to call for more sweeping action on drug pricing. During the same hearing one key GOP senator called on the committee to attach a bipartisan bill meant to incentive first generic development to user fee reauthorization.
The American Academy of Pediatrics (AAP) is pushing a slate of Pediatric Research Equity Act (PREA) reforms it wants attached to user fee reauthorizations, including requiring drug manufacturers developing orphan drugs to study those drugs for pediatric indications when the science shows the drug could be used to treat kids, and closing what the group sees as a loophole in the law allowing sponsors to benefit from orphan drug designations without conducting pediatric studies.
Eli Lilly disclosed list- and net-price increases as part of a new transparency initiative aimed at countering criticism of drug price increases, but Patients for Affordable Drugs co-founder David Mitchell said the initiative is a public relations move that does nothing to fix the core problem of rising drug prices.
The Health Resources and Services Administration again pushed back implementing the 340B ceiling price and civil monetary penalty rule, saying there are still substantial questions about the rule and signaling the administration may be taking a broader overall look at the implementation of 340B drug discounts and how this rule fits in.