- Kicking off the PDUFA VI Reauthorization Process (blogs.fda.gov)
Prescription Drug User Fee Act authorizes FDA to collect fees from pharmaceutical companies to help fund the agency’s drug review work...provide additional funding for FDA to hire staff, improve systems, and establish a better-managed review process...enables us to do more timely reviews of human drug applications….The current legislation, PDUFA V, is set to expire in September 2017…ideas for further enhancements, including:
- Further efforts to involve the patient perspective in drug development processes;
- Building on FDA’s Sentinel System for active surveillance of safety issues for medical products, including expanding its use as a source of data;
- Enhancing regulatory science initiatives, including the use of patient-reported outcomes and biomarkers.
- Sen. Brown introduces legislation to stop medication abuse (americanpharmacynews.com)
Sen. Brown … introduced…legislation, …Stopping Medication Abuse and Protecting Seniors Act, to address prescription drug abuse by cracking down on doctor shopping… creation of a Medicare lock-in program ..through better monitoring of prescription patterns on the part of doctors, pharmacies and patients...
- California lawmaker battles recall by anti-vaccine activists (newsdaily.com)
California lawmaker (Richard Pan, pediatrician) who made it harder for parents to opt out of vaccinating their children, a stance that earned him death threats, is now launching a campaign to save his job, days after the state certified a recall effort against him.
- Nevada expects to spend more on Medicaid than planned (rgj.com)
Many more Nevadans than expected have enrolled in Medicaid after Gov. Brian Sandoval opted to expand eligibility, meaning the state will be paying more than projected once the federal government scales back its support.
- Rising Drug Costs the Real Stumbling Block for Defense Measure (bloomberg.com)
..benefits for the estimated 9.6 million users of the Pentagon’s Tricare health system and resulting profits for retail drugstores including those run by CVS Health Corp., Walgreens Boots Alliance Inc. and Rite Aid Corp…Senate negotiators are supporting an Obama administration plan to increase co-payments for military retirees and families over 10 years, while House conferees oppose passing on so much of that cost to veterans.
- American Association of Diabetes Educators calls for provider status (drugstorenews.com)
… American Association of Diabetes Educators called on Congress to pass…two…bills, H.R. 1726, and S. 1345, which are known as The Access To Quality Diabetes Education Act of 2015…would amend title XVIII of the Social Security Act to recognize credentialed diabetes educators as providers of diabetes education services, including tele-health services, under part B of the Medicare program.
- Health records a sticking point in debate over national data breach notification standards (fiercehealthit.com)
Health records appear to be a big factor in why proposed data breach notification legislation has stalled,…The bill,…would set a national standard governing how companies must respond when hackers steal customer data….has been an outcry over its provisions to preempt stricter state-level data breach laws.
- State-level price caps? Massachusetts drug-cost pushback breaks new ground (fiercepharma.com)
Massachusetts is joining the state-level push to tamp down drug prices. Lawmakers are proposing new disclosures about pharma's pricing decisions, just as they are in other states. But unlike California's move to limit price increases, for instance, Massachusetts could actually cap prices on specialty meds… state officials would have the power to limit prices...
- Health Law Experiment Failed To Show Savings (khn.org)
$57 million experiment to deliver better, more efficient care at federally funded health centers struggled to meet its goals and is unlikely to save money,… run by the Department of Health and Human Services’ innovation center… paints a picture of understaffed clinics struggling to file reports and participate in conference calls…while they did their normal jobs of caring for patients and trying to get paid by insurance plans.
- New York authorizes pharmacists to administer additional immunizations (drugstorenews.com)
bill extending the authority of pharmacists and nurse practitioners to administer certain immunizations..shingles, meningitis, tetanus, diphtheria and whooping cough immunizations, in addition to administering influenza immunizations..