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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Rx Drugs
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.
Monday, 21 August 2017
FDA's Pediatric Advisory Committee will weigh the safety and benefits of using opioid products to treat cough in children as part of a two-day meeting next month that will also include discussion on whether several other drugs and devices can safely be used for children.
Friday, 18 August 2017
President Donald Trump signed Friday (Aug. 18) the FDA Reauthorization Act of 2017, a White House spokesperson tells Inside Health Policy.
Friday, 18 August 2017
Womens groups and other advocates groups are bracing for HHS to release an “interim final rule” that, if identical to a draft version leaked in May, would make it easier for employers to opt out of the Affordable Care Act's requirement to provide cost-free coverage of FDA-approved contraceptives.
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
In a newly published paper, two biosimilar experts make a scientific case for abandoning requirements that biosimilar sponsors conduct bridging studies between foreign biologics and U.S. licensed reference products before using non-U.S. samples for the testing required for approval.
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.
Thursday, 10 August 2017
Mylan is pointing the finger at FDA approval delays, and the agency's alleged prioritization of third, fourth and fifth generics over first generics and complex products, for the company's below forecasted quarterly earnings.
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.
Wednesday, 09 August 2017
FDA has formed an internal group to evaluate policies to modernize the agency's approach to the Hatch-Waxman generic pathway law, an FDA spokesperson tells Inside Health Policy.
Tuesday, 08 August 2017
FDA will hold a public meeting Sept. 18 to examine the experiences of the agency and stakeholders with structured benefit-risk assessments and approaches to incorporating patient perspectives in these assessments, according to a Tuesday (Aug. 8) agency notice.
Tuesday, 08 August 2017
There is not adequate evidence to show that the majority of abuse-deterrent opioids actually reduce opioid abuse, the Institute for Clinical and Economic Review's (ICER's) final report on the effectiveness of abuse-deterrent opioids finds.
Monday, 07 August 2017
FDA Commissioner Scott Gottlieb will unveil a plan to stop importation of unapproved foreign drugs -- namely synthetic Fentanyl -- from entering the United States through international mail facilities (IMFs), and will work with Congress to secure additional authorities to implement the plan, the commissioner announced to FDA staff Thursday (Aug. 3).
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
Fresh off a victory in the Senate, advocates for Right to Try legislation are urging the House to immediately take up the upper chamber's compromise bill when it returns in September, and the White House credits President Donald Trump for helping the move the amended bill through the Senate Thursday (Aug. 3).
Friday, 04 August 2017
A Democratic senator is redoubling calls for Congress to pass her bill granting FDA recall authority over cosmetics.
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.
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