Stakeholders are pushing the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act as an offset for renewing CHIP funding, multiple industry stakeholders tell Inside Health Policy.
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Drug Pricing
Wednesday, 23 August 2017
Wednesday, 23 August 2017
The insurance industry is hitting back at a new campaign that aims to make a point that medical management techniques, like step therapy and prior authorization, impair consumer access to medication.
Wednesday, 23 August 2017
Thirty states have drafted more than 60 drug price transparency bills aimed at identifying drug maker expenses and unveiling business practices of pharmacy benefit managers, according to an analysis by the National Academy for State Health Policy.
Tuesday, 22 August 2017
CMS' Advisory Panel on Hospital Outpatient Payment recommended Monday (Aug. 21) the agency drop a proposal to cut hospitals' Medicare reimbursement for drugs purchased through the 340B discount program.
Friday, 18 August 2017
Concerns over Risk Evaluation and Mitigation Strategies (REMS) abuse are largely misinformed and current reform proposals would create liability and diversion concerns for brand drug makers, an alliance of pharmaceutical companies and patient advocacy organizations argues in recent comments to FDA.
Thursday, 17 August 2017
The Department of Justice announced Thursday (Oct. 17) an EpiPen settlement of $465 million, which is the same amount DOJ denied having settled on last October when EpiPen maker Mylan announced the deal.
Thursday, 17 August 2017
The Health Resources and Services Administration proposed another delay, this time until July 2018, of a rule on the 340B drug discount program that sets ceiling prices and civil monetary penalties as the agency considers changing the regulation.
Thursday, 17 August 2017
In anticipation of what could be the most expensive cancer drug to date, the Patients for Affordable Drugs launched Thursday (Aug. 17) a national campaign demanding that Novartis factor in the considerable taxpayer investment in early research of the company's CAR-T cell therapy, which is at the forefront of individually tailored medicines that could cure certain cancers.
Monday, 14 August 2017
President Donald Trump used Merck CEO Kenneth Frazier's resignation from the White House manufacturing council on Monday (Aug. 14) as an opportunity to lash out at the pharmaceutical industry over high drug prices -- though Public Citizen blamed Trump for being “all talk, no action” when it comes to lowering those costs.
Wednesday, 09 August 2017
The Health Resources and Services Administration on Wednesday (Aug. 9) said it expects the new 340B registration system to be released in mid-September, but a spokesperson said that announcement does not apply to the 340B ceiling-price verification component.
Wednesday, 09 August 2017
A class-action lawsuit filed this week against CVS Health alleges the drugstore colludes with pharmacy benefit managers to charge customers more in co-pays for covered generic drugs than those customers would have paid for the drugs without insurance.
Monday, 07 August 2017
The drug importation bill being pushed by Sen. Bernie Sanders (I-VT), if passed, could constrain HHS' ability to object to opening up the drug supply chain to Organisation for Economic Co-operation and Development (OECD) countries and possibly open up the department to lawsuits, a former FDA lawyer tells Inside Health Policy.
Friday, 04 August 2017
A brand company facing a lawsuit over alleged abuses of Risk Evaluation and Mitigation Strategies tells FDA there is not clear authority for a brand maker to provide samples to a generic company without violating the REMS statute.
Tuesday, 01 August 2017
The Medicare Part D base beneficiary premium for 2018 dipped slightly for the first time in five years, and CMS told Inside Health Policy the base beneficiary premium is declining because rebates and other price concessions are projected to grow faster than drug costs.
Friday, 28 July 2017
The list price of the second Remicade biosimilar, Renflexis, is 20 percent lower than that of the first Remicade biosimilar, and doctors who prescribe Renflexis would likely get a good chunk of that 20 percent difference because both biosimilars are in the same billing code, sources say.
Thursday, 27 July 2017
Orphan Drug Act architect Henry Waxman is proposing multiple tweaks to the rare-disease law including shortening exclusivity periods, barring orphan exclusivity for off patent drugs, requiring greater transparency from orphan drug applicants and altering the tax credit system.
Thursday, 27 July 2017
Orphan Drug Act architect Henry Waxman is raising the possibility of tweaks to the rare-disease law including shortening exclusivity periods, barring orphan exclusivity for off patent drugs, requiring greater transparency from orphan drug applicants and altering the tax credit system.
Thursday, 27 July 2017
The architect of the generic pathway law is proposing tweaks to his signature legislation that include eliminating certain exclusivity protections, reducing or eliminating patent extensions and even rethinking whether exclusivity should be based on a set timeframe, according to a new report authored by former Rep. Henry Waxman (D-CA) and former Deputy HHS Secretary Bill Corr.
Thursday, 27 July 2017
A new report from the architect of the generic pathway law is floating possible tweaks to his signature legislation that include eliminating certain exclusivity protections, reducing or eliminating patent extensions and even rethinking whether exclusivity should be based on a set timeframe.
Monday, 24 July 2017
Congressional Democrats laid out Monday (July 24) a slate of proposals for lowering drug prices, including setting up an independent regulator to monitor “price gouging” of prescription drugs, allowing Medicare Part D to negotiate drug prices and requiring drug manufacturers to provide HHS with justification for any significant price hikes.
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