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Drug Pricing

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.

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 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

FDA is extending the public comment period for its draft guidance outlining how biosimilar sponsors can demonstrate that their products are interchangeable with other biologics, following extension requests from top trade associations.

Friday, 10 March 2017

The White House has indicated that the drug pricing measures to be included in phase three of health reform will deal with streamlining FDA and bringing generic competition to market.

Wednesday, 08 March 2017

House Republican leaders and the Trump administration said Tuesday (March 7) they plan to pass medical malpractice and drug price legislation in the third stage of the three-phase scheme to repeal and replace the Affordable Care Act.

Tuesday, 07 March 2017

After President Donald Trump tweeted Tuesday (March 7) that he is working with the drug industry on a system to promote competition and bring down drug prices, a White House spokesperson declined to provide specifics and reiterated the president is committed to making drugs more affordable and cutting regulations on drug companies.

Tuesday, 07 March 2017

After President Donald Trump tweeted Tuesday (March 7) that he is working with the drug industry on a system to promote competition and bring down drug prices, a White House spokesperson declined to provide specifics and reiterated the president is committed to making drugs more affordable and cutting regulations on drug companies.

Monday, 06 March 2017

States can use alternative payment models to bring prescription drug companies to the negotiating table and lower prices of drugs in the Medicaid drug rebate program without changing laws, researchers from Oregon Health & Science University told congressional advisers on Friday (March 3).

Monday, 06 March 2017

Three key GOP senators are asking the Government Accountability Office to investigate whether FDA's orphan drug program is incentivizing rare disease drug development, and to propose any regulatory or legislative changes that the government watchdog feels are necessary to reform the program, according to a letter obtained by Inside Health Policy.

Friday, 03 March 2017

Congressional Medicare advisers plan to vote on Medicare Part B drug pay recommendations in April, and at a meeting this week continued to debate draft policies such as requiring HHS to use a common billing code to pay for a reference biologic and its biosimilars and a market-based alternative to the current Part B drug pay system.

Friday, 03 March 2017

Rep. Doug Collins led an hour-long bipartisan broadside against pharmacy benefit managers on the House floor Thursday (March 2), which the Georgia Republican started by referring to them as terrorists, and at one point Collins went after the head of the pharmacy benefit manager trade group by name.

Thursday, 02 March 2017

Over 180 off-patent drugs are currently without generic competition, FDA drug center chief Janet Woodcock told lawmakers Thursday during a House hearing on a new bill meant to incentive generic development.

Thursday, 02 March 2017

Key House Energy & Commerce lawmakers expressed concern during a user fee reauthorization hearing Thursday (March 2) over FDA’s 9 percent first-cycle approval rate for generics, as well as the progress made in implementing the biosimilars pathway -- despite assurances from industry and FDA that the programs are improving the agency’s approval numbers.

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