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Scott Gottlieb took over as head of the Food and Drug Administration with a somewhat unconventional agenda...He quickly won over skeptics...And while the agency's core missions of drug and food safety remain unchanged, Gottlieb was able to elevate different, specific issues into the limelight...e-cigarettes, opioids and drug prices gave the agency new focus at the highest level...Gottlieb's willingness to call out drugmakers for what he memorably dubbed "shenanigans" and "Kabuki drug pricing" pushed the industry in a more public manner than past agency chiefs...Under his leadership, the FDA flagged anti-competitive concerns including drugmaker abuse of the REMS system and citizen petitions, as well as publishing a list of off-patent drugs with no generic competition...READ MORE

Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

NACDS and the National Community Pharmacists Association held a briefing this week for the Congressional Doctors Caucus...chaired by Rep. Phil Roe...comprised of 16 medical providers in Congress who use their medical expertise to develop patient-centered healthcare policy...NACDS and NCPA discussed the Centers for Medicare & Medicaid Services’ recently released proposed rule—Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses—and explained the serious repercussions of direct and indirect remuneration (DIR) fees and the impact they can have on patient access to care and on pharmacies, who are struggling to maintain their businesses amid the uncertainty caused by the retroactive fees. The groups noted that they have advocated strongly for DIR reform in the CMS proposal because it will benefit pharmacies and the patients they serve.

The Food and Drug Administration and manufacturers did not take action when evidence emerged that potentially lethal fentanyl products were being inappropriately prescribed to patients, new research...shows...even as evidence emerged that as many as half of patients were taking dangerous medications known as TIRFs that should never have been prescribed to them, the FDA and fentanyl makers did not review prescribing records of even a single physician to consider disqualifying them from the program, which would have prevented them from prescribing the products...The study focused on Transmucosal Immediate-Release Fentanyls, or TIRFs, which are more dangerous than most prescription opioids on the market due to their very high potency and rapid onset. TIRFs are designed to get into the bloodstream within seconds, and because of their risks, were approved by FDA only for adult cancer patients "who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain."

The Dutch hospital (Erasmus Medical Center in Rotterdam) has been offering it (lutetium octreotate) to patients for more than a decade at 16,000 euros ($18,000) for one course of treatments. Drug firm Novartis, which in 2018 acquired rights to sell it in Europe, is asking more than five times that for its proprietary version, Lutathera...Thomasa (Emar Thomasa) is part of a protest against high drug prices launched by an unlikely group of rebels: Dutch pharmacies...Amsterdam’s University Medical Center (UMC) and the Transvaal Pharmacy in The Hague - have vowed to bypass drug company products and make treatments for a handful of rare diseases themselves, exercising their right to “compound” medicines...Drug companies have raised concerns about the safety of compounded medicines that have not been approved by European regulators. But the specialized compounding pharmacies, which have on-site laboratories, have been backed by the Dutch government as part of efforts to tame rapidly rising medicine costs...READ MORE

Endo International Plc said...the U.S. health regulator has decided...not to include blood pressure treatment vasopressin in its list of drugs that can be used in compounding, in a boost to the drugmaker that makes the only FDA-approved version of the product...The company had sued the Food and Drug Administration in October 2017, alleging that the agency had improperly authorized the bulk compounding of hundreds of drugs, including “essentially a copy” of Endo’s Vasostrict...The agency’s decision renders the sale of compounded products containing vasopressin unlawful, unless manufactured using an FDA-approved product, Endo said...READ MORE

, welcome to This Week in Managed Care from the Managed Markets News Network
Jaime Rosenberg

Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

The legislation, which GOP Assembly members Melissa Hardy and Glen Leavitt presented to the Assembly Commerce and Labor Committee on Monday, would bar pharmacy benefit managers, or PBMs, from stopping a pharmacist from telling patients about the availability of a less expensive, generic or more effective drug, or a less expensive manner of purchasing a drug. The proposal builds upon a pharmacy gag ban passed by the Legislature in 2017 that prevented PBMs from blocking pharmacists from sharing information about the copay or coinsurance for a prescription drug or the clinical efficacy of a less expensive alternative drug...READ MORE

Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.