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Rx Drugs

Friday, 28 April 2017

The Association For Accessible Medicines is urging heads of two key congressional committees to include Risk Evaluation Mitigation Strategies (REMS) reform in the FDA user fee reauthorization package, as well as provisions to ensure companies do not use self-imposed restricted distribution systems to block generics from coming to market.

Friday, 28 April 2017

The rift between Anthem and Express Scripts makes a strong case for the government forcing pharmacy benefit managers to disclose rebates and price concessions they negotiate with drug makers, according to Sen. Ron Wyden (D-OR), who wrote a PBM transparency bill, and Avalere Health Vice President Rujul Desai said the fallout increases the likelihood of transparency legislation gaining traction.

Thursday, 27 April 2017

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.

Thursday, 27 April 2017

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.

Thursday, 27 April 2017

The CMS Chief Actuary is supposed to determine by the end of this week whether the Independent Payment Advisory Board will be triggered next year -- a determination that could give President Donald Trump a clear shot at making good on his campaign promise to curb drug prices -- but the decision is expected to be several months late.

Thursday, 27 April 2017

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.

Wednesday, 26 April 2017

Many of the policies that the National Health Council recommended Tuesday (April 25) for curbing health care costs deal with the price of drugs, but the patient-led organization, which includes the pharmaceutical lobby as a board member, proposes policies that are among the least controversial within the drug industry.

Tuesday, 25 April 2017

The U.S. Supreme Court will hear 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.

Tuesday, 25 April 2017

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).

Tuesday, 25 April 2017

Scott Gottlieb lays 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.

Monday, 24 April 2017

The American Academy of Pediatrics laid out priorities for user fee reauthorization that would expand on the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA), including making permanent the BPCA's National Institutes of Health program that funds studies on use of off-patent drugs in children.

Friday, 21 April 2017

FDA announced Friday (April 21) approval of Samsung Bioepsis Co LTD's biosimilar for Remicaid, 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.

Friday, 21 April 2017

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.

Friday, 21 April 2017

Drug manufacturers are urging the Health Resources and Services Administration to rework the 340B ceiling price rule after HRSA pushed back its implementation citing ongoing questions, but 340B providers say the rule should be implemented immediately because it is already more than six years after the statutory deadline and stakeholders have had many chances to weigh in.

Friday, 21 April 2017

Marathon Pharmaceuticals announced Thursday (April 20) that it is resigning from all of its trade association memberships, including the Pharmaceutical Research and Manufactures of America, following closure of a deal to sell its its Duchenne muscular dystrophy drug, Emflaza, which the company was accused of price gouging earlier this year.

Thursday, 20 April 2017

The generic drug lobby recently answered calls from the Trump administration to highlight regulations that negatively impact domestic manufacturing by telling the Commerce Department it wants FDA to withdraw its proposed generic drug labeling rule and quality metrics data guidance, and to revamp a biosimilar “deemed to be a license” guide.

Wednesday, 19 April 2017

The Association for Accessible Medicines is urging Maryland Governor Larry Hogan (R) to veto the state's first-in-the-nation generic drug price gouging bill, arguing the measure would give the state attorney general too much power, unfairly carve out the brand industry and potentially violate the constitution, according to a letter hand-delivered to Hogan April 19 and obtained by Inside Health Policy.

Monday, 17 April 2017

Beneficiary advocates are upset by CMS' move to stop reviewing drug formularies as part of the Qualified Health Plan (QHP) certification process for federally facilitate marketplace states that conduct plan management, arguing that punting to the states could weaken patient protections.

Monday, 17 April 2017

The Maryland state legislature passed the nation's first bill allowing a state attorney general to sue pharmaceutical makers for price gouging on essential generic and off-patent drugs, prompting outcry from the generic trade group, the Association for Accessible Medicines, which argues the bill's language is too ambiguous and creates a level of uncertainty for its members.

Monday, 17 April 2017

FDA announced Monday (April 17) that it will convene an advisory committee meeting in May to consider what could become the first FDA-approved biosimilar to Amgen's Epogen/Procrit (epoetin alfa).

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