- PhRMA and BIO Initiate Litigation to Challenge Unconstitutional Provisions of Nevada’s SB 539 (phrma.org)
The Pharmaceutical Research and Manufacturers of America the Biotechnology Innovation Organization today initiated litigation in the United States District Court for the District of Nevada challenging provisions of SB 539, a Nevada law that would violate patent rights and negate trade secret protection for designated diabetes medicines in a way that would harm patients and chill future biomedical innovation...PhRMA and BIO seek a declaration from the Court that the challenged provisions of SB 539 are preempted by federal law and violate several provisions of the United States Constitution...also seek an injunction prohibiting the implementation or enforcement of these challenged provisions...The Complaint alleges that provisions of SB 539 violate the Constitution in at least four ways:
- by interfering with federal patent law;
- by interfering with federal trade secret law;
- by violating the Takings Clause of the Fifth Amendment of the United States Constitution which prohibits government from taking property without just compensation; and
- by violating the dormant Commerce Clause of the United States Constitution, which prohibits Nevada from impeding commerce in other states.
- Herpes vaccine company backed by Peter Thiel vows future testing will follow FDA guidelines after offshore trial sparks ethics furor (cnbc.com)
The CEO of a herpes vaccine company at the center of a controversy over an offshore clinical trial,,,said that future testing of the drug will follow U.S. Food and Drug Administration oversight rules, as demanded by a new group of financial backers that includes venture capitalist Peter Thiel...In an impassioned interview, Rational Vaccines Chief Agustin Fernandez said he feared the great promise of the vaccine developed by the late university professor William Halford was being overshadowed by criticism over Halford's decision to test the drug using American patients on the West Indian nation of St. Kitts and Nevis without monitoring by the FDA or an institutional review board, as is traditional...Fernandez...said that he now understands it is necessary from now on to conduct further trials following FDA oversight standards if Rational Vaccines hopes to market the vaccine in the United States...
- New Oregon Law Lets Pharmacists Prescribe Formulary Drugs, Devices (ashp.org)
As early as January 1, Oregon pharmacists will be permitted to prescribe and dispense drugs and devices listed on a formulary to be established by the state board of pharmacy under a bill recently signed by Governor Katherine Brown...The formulary, according to the new law, may contain such "post-diagnostic" items as diabetic testing supplies, smoking-cessation aids, epinephrine autoinjectors, albuterol inhalers, rapid strep tests, and spacers for inhalers...Other possibilities mentioned in the law are discharge medications during transitions of care and emergency refills of insulin..."Nothing about this is new territory," said Michael E. Millard, cochair of the Oregon Society of Health-System Pharmacists...Legal and Regulatory Affairs Committee, in explaining why the prescribing bill passed the legislature on the first try...the bill builds on past legislation and advances pharmacy practice a step further...
- Heather Korbulic, Executive Director of the Silver State Health Exchange – Nevada NewsMakers (nevadanewsmakers.com)
Nevada NewsMakers: Host: Sam Shad - Guest: Heather Korbulic, Executive Director of the Silver State Health Exchange
- Law firm drops suit alleging CVS gouged generic consumers, plans to refile (fiercepharma.com)
The plaintiff in a proposed class action lawsuit against CVS dropped her claims...After making a series of allegations that pharmacy giant CVS was gouging generic drug consumers who paid with insurance, the plaintiff in a proposed class action lawsuit dropped her claims...Megan Schulz alleged she paid more through insurance to get a generic drug than if she’d just paid cash. The suit also alleged pharmacy "copays" were really payments to pharmacy benefit managers, set up by confidential deals. CVS refuted the allegations and said in a statement...that it’s pleased the suit has been dismissed..."The complaint contained numerous demonstrably false assertions that a reasonable pre-filing investigation by the law firm would have discovered,"..."As such, we are pleased that the suit has been voluntarily dismissed.",,,"We plan to refile the lawsuit against CVS related to its generic drug pricing scheme promptly,"..."Our case against Walgreens was not dismissed and will remain on file until we achieve a just outcome for consumers."
- This Week in Managed Care: September 1, 2017 (ajmc.com)
Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- First Gene-Transfer Therapy Approved for U.S. Market (ashp.org)Pioneering cancer drug, just approved, to cost $475,000 — and analysts say it’s a bargain (statnews.com)
FDA...announced the approval of tisagenlecleucel, a first-in-class chimeric antigen receptor (CAR) T-cell immunotherapy consisting of genetically modified autologous T cells, for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL) in children and young adults...After modification in the laboratory and infusion back into the patient, the CAR T cells target and eliminate both normal and malignant CD19-expressing B cells. The genetic modification enhances the initiation of T-cell activation and the persistence of the transformed T cells...Novartis will market tisagenlecleucel as Kymriah. Labeling for the product states that it is indicated in patients up to age 25 years with ALL that is refractory or in second or later relapse...Tisagenlecleucel has an FDA-required risk evaluation and mitigation strategy (REMS) program that includes elements to assure safe use. The labeling states that the immunotherapy is available "only through a restricted program."...
- Arizona accuses drugmaker Insys of fraudulent opioid marketing (reuters.com)
Arizona sued Insys Therapeutics Inc...accusing the drugmaker of engaging in a fraudulent marketing scheme aimed at increasing sales of a fentanyl-based cancer pain medicine called Subsys...The lawsuit by Arizona Attorney General Mark Brnovich in Maricopa County Superior Court in Phoenix comes during a series of federal and state investigations centered on Insys’ drug Subsys amid a national opioid addiction epidemic...The lawsuit accused Arizona-based Insys of paying doctors sham speaker fees in exchange for writing prescriptions of Subsys and of misleading insurers into believing patients who were prescribed the opioid had cancer when they actually did not...The lawsuit seeks an injunction, restitution for customers and the disgorgement of any illegally earned profits…
- Week in Review: September 1, 2017 (pharmacytimes.com)
Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- Nevada earns D on nonprofit’s new health-care report card (reviewjournal.com)
A new nonprofit created by heavy hitters from Nevada’s business and medical communities gave the state a D grade on its first report card on the state’s health care system...The report card was released...by the Nevada Medical Center and is intended to focus attention on improving access to quality health care in the state...Larry Matheis, the NMC’s CEO, said the report card will help state leaders focus on the gaps that must be filled to improve Nevada’s medical standing. Currently, he said, the state’s medical system “resembles a series of isolated communities…due to the lack of collaboration among medical professionals and the dearth of thought given to enhancing our community’s reputation.”...The report card’s grades, based on analysis of data supplied by the Centers for Disease Control and Prevention and other government agencies, show how Nevada fares in the categories of health care access, chronic disease, nutrition and activity, mental health and substance abuse. The grades weren’t all bad, with the state receiving a passing “C” grade on chronic disease and a better-than-average “B” on nutrition and activity.