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Rx Drugs

Friday, 24 March 2017

FDA drug center head Janet Woodcock told Inside Health Policy that her recent statement on the impact of proposed changes to the Pediatric Research Equity Act (PREA), which appeared to go against previous HHS statements, was directed solely at a subset of pediatric orphan diseases.

Wednesday, 22 March 2017

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.

Wednesday, 22 March 2017

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 Agreement (PDUFA) will bring important resources to the breakthrough effort.

Tuesday, 21 March 2017

The House oversight committee will hold 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.

Tuesday, 21 March 2017

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.

Tuesday, 21 March 2017

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.

Monday, 20 March 2017

A recent journal article finding a majority of the largest national patient advocacy groups have financial ties to industry has sparked debate on whether Congress or FDA should impose new transparency measures to ensure such groups' advocacy at agency advisory committee and public meetings is accurately represented.

Friday, 17 March 2017

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.

Friday, 17 March 2017

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.

Friday, 17 March 2017

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.

Friday, 17 March 2017

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.

Friday, 17 March 2017

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.

Thursday, 16 March 2017

Sen. Bernie Sanders (I-VT) and House Oversight ranking Democrat Elijah Cummings (MD) are questioning whether FDA took proper steps to ensure the integrity of the data used to support the recent approval of Marathon Pharmaceuticals' Duchenne muscular dystrophy drug, and whether the agency took responsibility to ensure Marathon did not abuse the orphan drug and pediatric priority review voucher programs.

Thursday, 16 March 2017

President Donald Trump's budget blueprint sparked concerns among multiple stakeholders and legislators Thursday (March 16) for putting stable appropriations funding and already-negotiated FDA user fee agreements at risk.

Thursday, 16 March 2017

President Donald Trump’s proposed budget blueprint calls for industry to double up on user fees to fully pay for FDA premarket approvals in exchange for administrative reforms aimed at speeding products to market.

Thursday, 16 March 2017

President Donald Trump’s proposed budget blueprint calls for industry to double up on user fees to fully pay for FDA premarket approvals in exchange for administrative reforms aimed at speeding products to market.

Thursday, 16 March 2017

President Donald Trump again called for bidding to bring down drug prices at a rally in Nashville, TN Wednesday evening -- coming a week after the White House appeared to signal its drug price-reduction strategy was instead focused on reforming FDA's generic drug approval policies.

Wednesday, 15 March 2017

House Energy & Commerce health subcommittee Chairman Michael Burgess (R-TX) doubled down Wednesday (March 15) on his criticism that FDA is moving too slowly to institute the biosimilar pathway.

Wednesday, 15 March 2017

Sen. Ron Wyden (D-OR) introduced Wednesday (March 15) a drug-price transparency bill that would make pharmacy benefit managers disclose rebates, and he is garnering support for a second bill to make drug companies publicly justify price spikes, according to a letter seeking support from fellow lawmakers.

Tuesday, 14 March 2017

Newly confirmed CMS chief Seena Verma and FDA chief-nominee Scott Gottlieb, if confirmed, face immediate orders from the White House to craft plans to reorganize their agencies to improve efficiency, shift functions to the states or local governments, and merge or shut down any functions for which costs aren't justified by public benefits or are redundant with work of other agencies.

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