- 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.
- UNLV grads assist in artificial pancreas research (reviewjournal.com)
…far from building an artificial organ, a breakthrough system being developed with the help of two alums from the University of Nevada, Las Vegas is bringing the diabetic community closer to one than ever before…Tomas Walker and Aimee Jose, who graduated…from...nursing school, are each playing a role in the creation of a so-called artificial pancreas system,..works like this: Three separate components with tiny needles are attached to the wearer's abdomen. The first two are pumps — one is filled with the insulin hormone, and the second is filled with another hormone called glucagon…third is a continuous glucose monitor,.. it tells the pumps how frequently they should secrete hormones into the body to regulate blood sugar levels.
- Patients Strongly Oppose Prescription-Only Pseudoephedrine (pharmacytimes.com)
..vast majority of patients wants continued access to OTC medications containing pseudoephedrine and opposes making the drugs prescription-only…This conclusion comes from an Asthma and Allergy Foundation of America survey of more than 2000 adults … who experienced cold, cough, flu, asthma, or allergies…71% of patients unfavorably view pharmacies and grocery stores that remove OTC medications containing PSE from their shelves..
- Merck & Co. plans over 2,500 manufacturing job cuts (in-pharmatechnologist.com)
An SEC filing reveals Merck has cut 29,160 jobs in five years, and over 2,500 more may be on the way….company’s restructuring programme began soon after Merck acquired Schering-Plough in late 2009. As well as tens of thousands of job cuts in sales,….. eliminated 1,950 jobs in the first half of 2015...
- Sen. Manchin blasts FDA for OxyContin approval for children over 11 (wvva.com)CDER Conversation: Pediatric pain management options (fda.gov)
Senator Joe Manchin says he is "ashamed" and "disgusted" with the Federal Drug Administration's recent decision to allow physicians to prescribe OxyContin to children. Manchin calls the decision "a horrifying example of the disconnect between the FDA approval process and the realities of the deadly epidemic of prescription drug abuse are having on our communities." He is calling for a Senate investigation.
- Purdue Pharma unveils opioid abuse prevention website (drugstorenews.com)Team Against Opioid Abuse (teamagainstopioidabuse.com)
Purdue Pharma is launching a new effort to prevent opioid abuse…announced its new Team Against Opioid Abuse website that’s meant to instruct people about how to reduce opioid abuse and misuse and inform about abuse-deterrent technologies….importance of preventing abuse of prescription drugs and outlines FDA guidelines on abuse-deterrent labeling…includes information on how to identify opioid formulations with abuse-deterrent properties for healthcare professionals…
- The Pharmacist’s Role in Immunizations (pharmacytimes.com)
Rupal Mansukhani, PharmD, clinical assistant professor at the Ernest Mario School of Pharmacy at Rutgers, talks about how pharmacists can play a bigger role in providing immunizations. (video)
- Planned Parenthood Seeks Injunction After Abortion Allegations (health.wusf.usf.edu)FL Planned Parenthood Inspections Find Violations (health.wusf.usf.edu)
Planned Parenthood fired back..against allegations that three Florida abortion clinics provided second-trimester abortions without proper licenses, seeking an emergency injunction against the state Agency for Health Care Administration "to protect women's access to safe, legal abortion."… grounds for the injunction,… AHCA was ignoring a 2006 agency rule, which defined the first trimester as "extending through the completion of 14 weeks of pregnancy…
- CMS issues guidance on AWP compliance (drugstorenews.com)
Centers for Medicare and Medicaid Services…issued guidance to all Medicare Part D plan sponsors regarding the Part D program's "any willing pharmacy" requirement…To comply with the AWP requirement,.. all…plans must have posted standard contracting terms and conditions… This new guidance should help reduce the likelihood of repeating the debacle of early 2015 that affected approximately 400,000 Medicare beneficiaries…
- PharmTalk – Psychiatric Pharmacy (pharmacy.arizona.edu)
PharmTalk is a special production from the University of Arizona, College of Pharmacy that features Keith and Kevin Boesen.
Some pharmacists specialize in understanding the drugs that help people with behavioral health issues. This time the team visits with a hospital-based pharmacist who works with psychiatric patients.