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New York Governor Andrew Cuomo has...unveiled a first-of-a-kind proposal to curb “exorbitant” prescription prices in the Empire State...New York will create a “review board” to determine the “fair price” for certain expensive drugs under the plan...and then the state will mandate that Medicaid won’t pay more than that amount for its purchases. When a company charges Medicaid more than the board’s set price, it’ll owe a “rebate for any amount” in excess...The proposal would also impact private markets. If a pharma company sells into the state at a price higher than the board’s set amount, that sale will be hit with a surcharge; the government will collect that money and reallocate it “back to the insurance providers to reduce the cost of insurance.”…Lastly, Cuomo's proposal includes new restrictions on pharmacy benefit managers, forcing them to register with the state and disclose “financial incentives or benefits for promoting the use of certain drugs, as well as other financial arrangements affecting customers,”...Then, under the plan, PBMs must have a license beginning in 2019 and the state could revoke those licenses for “deceptive, unfair, or abusive business practices.”...

Kelly Walsh, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

A federal judge...ruled that Mumia Abu-Jamal should be provided new medications by the state to treat his hepatitis C infection...U.S. District Judge...ordered that Abu-Jamal, who is serving life in prison for the 1981 killing of Philadelphia Police Officer Daniel Faulkner, must be seen by a doctor within 14 days to determine if there is a medical reason he should not get the expensive drugs...If...is medically cleared, the state must provide him with recently developed direct-acting antiviral medication, also known as DDA (DAA, Direct-Acting Antivirals)... Department of Corrections...has argued in court filings that Abu-Jamal has not met the criteria for treatment...The state has about 7,000 inmates with hepatitis C, and treating them - at a cost of $84,000 to $90,000 per person - would cost $600 million... DOC will no doubt appeal this ruling...

The FDA has proposed two studies that would seek to determine how well consumers and healthcare providers can identify deceptive prescription drug claims in branded marketing materials...The first study would investigate the ability of consumers and HCPs to detect false or misleading promotions when showed two mock pharmaceutical websites, one site oriented toward providers and a separate one for consumers...The second study would focus on examining whether the participants can identify the difference between implicit and explicit deceptive claims...is the claim overtly wrong? Or is it misleading because it understates certain information?...and whether those claims affect their attitudes and intentions toward the promoted drug...The notice comes as the agency grapples with an industry pushing for the sharing of truthful, non-misleading information with more stakeholders outside of a drug's approved label

A Pennsylvania hospital has agreed to pay $510,000 in fines after an inpatient pharmacist stole controlled substances. The pharmacist, Renata Dul, was found to have stolen more than 35,000 units of a controlled substance, including oxycodone….Abington Memorial Hospital disclosed the pharmacist’s actions to the DEA after detecting a discrepancy during inventory, which prompted an investigation that revealed pill count discrepancies, missing or incomplete medication inventories, and altered or missing drug records. An internal investigation pinpointed Dul’s ability to exploit a gap in the software used to track prescription medications...AMH agreed to pay a fine in response to allegations that their failures in control and practices enabled Dul to divert controlled substances for illegal, non-medical uses...

The National Community Pharmacists Associatio...reached out to Republican congressional leaders to provide the community pharmacist perspective on repeal and replacement of the Affordable Care Act and potential Medicaid changes...Specifically, NCPA recommended any repeal and replacement of ACA include the following provisions:

• Preserve prescription drug coverage as an essential benefit to help reduce overall health costs;
• Require a robust pharmacy network that includes meaningful access to retail pharmacies, including independent pharmacies, for patients to fill their prescriptions and promote proper adherence;
• Maintain current definition for Average Manufacturer Price that is used to determine Medicaid reimbursements;
• Retain sections of the ACA that were dedicated to improving Medicare Part D medication therapy management programs, including an annual comprehensive medications review, and build upon it to further integrate pharmacists into the health care delivery system; and
• Keep transparency provisions requiring pharmacy benefit managers serving exchange plans and Medicare Part D to disclose to HHS the generic dispensing rate for retail and mail order pharmacies, the amount of the rebates collected, the amount passed onto the health plan and the total difference between what the PBM charged the plan and what it paid out to pharmacies

The FDA says the unit of Clorox that manufactures povidone-iodine drug products needs to clean a big mess at a plant in Meriden, Connecticut, which failed to follow steps to insure the sterility of its wound products—products that the FDA also said are “unapproved.”...The agency...posted a warning letter for the Aplicare plant…(it) said...the plant failed to implement adequate microbial controls...some of its products are unapproved because they do not comply with the FDA’s OTC Final Monograph for Topical Antifungal Drug Products.

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

In a departure from the way the WHO and Europe name biologics, the US Food and Drug Administration...finalized long-awaited guidance on how biosimilars and their biologic reference products’ names should include a four-letter, FDA-designated meaningless suffix attached at the end of the nonproprietary name...The decision to finalize this guidance follows...but large opposition to the idea of using meaningless rather than meaningful suffixes that could make it easier to distinguish the manufacturers of the products...For example...Sandoz’s Zarxio, which includes a non-proprietary name with a meaningful suffix (Sndz for Sandoz): filgrastim-sndz...But FDA has said it will change Zarxio’s nonproprietary name from filgrastim-sndz to “filgrastim-bflm." And Amgen's Neupogen (filgrastim) would be changed to "filgrastim-jcwp."...But these suffix rules do not necessarily apply to all related biologics...some instances it has designated a proper name that includes an identifier attached as a prefix to distinguish the products from previously licensed biologics. For example, with ado-trastuzumab emtansine, FDA includes a unique prefix, which it says was necessary to minimize certain medication errors and to facilitate pharmacovigilance.

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