- Endo gains on favorable FDA drug compounding decision (reuters.com)FDA In Brief: FDA finalizes guidance on evaluating the clinical need for outsourcing facilities to compound drugs with bulk drug substances; provides final decision on two substances (fda.gov)
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
- Pfizer unit Meridian under civil investigation by U.S. Attorney (reuters.com)
Pfizer Inc said...it received a request for documents as part of a U.S. investigation related to quality issues involving the manufacture of auto-injectors at its Meridian Medical Technologies site...Meridian, a unit of Pfizer that manufactures EpiPen injectors...has been hit by a series of manufacturing problems in recent years...In 2017, Meridian had received a warning letter from the Food and Drug Administration. The FDA said Meridian had failed to thoroughly investigate product failures, including EpiPen products that were associated with patient deaths and severe illnesses. It said the company failed to take corrective actions until FDA’s inspection...
- Novartis faces shareholder criticism over drug prices at AGM (reuters.com)
Novartis’s shift into high-tech drugs won praise for providing patients with new options but criticism over prices that may run into the millions of dollars at the Swiss drugmaker’s annual general meeting...Swiss shareholder group Actares said insurance systems are being “taken hostage” by high prices for life-saving drugs. It called out Novartis’s $475,000 cancer cell therapy Kymriah and its still-unapproved gene therapy for spinal muscular atrophy that Novartis contends is cost-effective at $4-$5 million per patient, while independent groups have concluded its value is less than that.
- FDA oversight of the prescribing of fentanyl products is inadequate, report finds (healthcarefinancenews.com)Assessment of the FDA Risk Evaluation and Mitigation Strategy for Transmucosal Immediate-Release Fentanyl Products (jamanetwork.com)
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."
- Lawmakers hear bill to ban rules barring pharmacists from telling patients about less expensive, generic drugs (thenevadaindependent.com)
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
- China slashes tax to stimulate domestic orphan drug market (pharmaceutical-technology.com)
China has announced a plan to slash the Value Added Tax on 21 rare disease therapies and four active pharmaceutical ingredients, dropping it by 80% in a bid to stimulate the domestic rare disease therapy market and drop the prices of the therapies...China is currently suffering from a shortage of rare disease therapies; of the 44 globally available rare disease therapies, only 19 are currently marketed within China, and of these 19, all are priced out of reach for the average Chinese patient. And with an estimated population of nearly 20 million people suffering from a rare disease within China, this is a huge area of unmet need...
- March 1 Pharmacy Week in Review: Thousands of Lives Saved Due to Improvements in Breast Cancer Treatment, Sesame Allergies Are Increasing (pharmacytimes.com)
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.
- Purdue eyes bankruptcy filing to cope with mounting opioid accusations: Reuters (fiercepharma.com)Exclusive: OxyContin maker Purdue Pharma exploring bankruptcy -sources (reuters.com)
Purdue Pharma may file for bankruptcy to get out from under thousands of lawsuits blaming the opioid maker and its aggressive marketing for the addiction crisis...The drugmaker is battling a weight of litigation, including state claims that target its executives and founding family, claiming it misled doctors and patients and marketed its painkillers too aggressively, helping to create a nationwide opioid crisis. Now, the company is exploring bankruptcy as a way to cope with the amassing litigation...A bankruptcy filing would halt proceedings in the lawsuits and allow Purdue to negotiate with plaintiffs under the watch of a bankruptcy judge...READ MORE
- This Week in Managed Care: March 1, 2019 (ajmc.com)
, welcome to This Week in Managed Care from the Managed Markets News Network
Jaime Rosenberg - Executives from seven major drug companies will be grilled about the high cost of their medications at a Senate panel on Tuesday morning. (ksat.com)
The hearing is the latest volley in Washington's battle against soaring drug prices, which has become a top priority for the Trump administration, as well as many Democratic and some Republican lawmakers...Executives from companies including Pfizer, Johnson & Johnson and AbbVie, will appear before the Senate Finance Committee and likely face tough questions from the panel's new chairman, Republican Sen. Chuck Grassley of Iowa...