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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.

Lawmakers are considering adding a measure aimed at fighting high drug prices to an upcoming spending deal, in what would be a rare defeat for the powerful pharmaceutical industry...The measure, known as the Creating and Restoring Equal Access to Equivalent Samples Act, is intended to prevent branded drug companies from using tactics to delay competition from cheaper generic drugs...Pharmaceutical companies are pushing back and lobbying against the measure, arguing it would harm patient safety and open companies up to wasteful lawsuits...But they might not be successful in their effort. Lobbyists and congressional sources say the measure could be added to a long-term government funding bill as a way to help pay for higher budget caps. The measure is estimated to save more than $3 billion...The measure would allow a generic company to develop its own safety protocol for a drug rather than have to develop a shared protocol with the branded company. Supporters of the bill say there would still be rigorous standards in place to ensure safety...The bill would also allow generic drug makers to sue to obtain the samples they need. Powaleny warned the bill would lead to “wasteful litigation between companies.”

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

New pilot program to evaluate disclosure of clinical study reports...As part of its efforts to enhance transparency around drug approval decisions, the FDA is exploring ways it can continue to build on its obligation to share information…The agency is especially focused on information that can improve patient care and better inform providers about the products they prescribe. One place where it is evaluating how it can release information that may better inform scientists, providers, and patients is clinical study reports (CSRs)...The FDA has launched a pilot program to evaluate whether disclosing certain information included within CSRs following approval of an NDA improves public access to drug approval information...The FDA intends to post the parts of the CSRs that were most important to the agency’s assessment of the safety and efficacy of the drug, specifically, the study report body, the protocol and amendments, and the statistical analysis plan for each of the participating product’s pivotal studies...

Shares of generic-drug makers including Mylan NV and Teva Pharmaceutical Industries Ltd. fell after the Justice Department’s antitrust division said it might sue them for damages in a price-fixing probe...If taxpayers were overcharged because drugmakers conspired to raise the price of drugs, the Justice Department will consider suing to seek damages, Makan Delrahim, the division’s chief, said...“To the extent that taxpayers have had to pay that bill, I think the taxpayers should recover,” he said. “We will get involved on the civil side and recover damages for the U.S. government.”...Mylan dropped as much as 3.1 percent after the comments and traded down 0.6 percent to $46.25 at 1:37 p.m. in New York. Teva’s U.S. depositary receipts dropped as much as 2.8 percent and were down 1.5 percent to $20.41 and Endo International Plc fell 5.6 percent to $6.92...The three drugmakers are among more than a dozen companies targeted by the Justice Department and state attorneys general in a multi-year investigation into generic drug price-fixing. So far, the probe has led to guilty pleas from two former executives of Heritage Pharmaceuticals...

Several hundred hospitals that plan to form their own generic drug company are eyeing making "about 20" pharmaceutical products whose existing versions either cost too much or are in short supply for no good reason...Dr. Marc Harrison, chief of...Intermountain Healthcare, during an interview on CNBC's "Closing Bell," would not identify the existing drugs that the new company wants to replicate on its own, or have done on a contract basis..."We think it will be early '19 before our first drugs come to market."...the group also is hoping to possibly get additional financing from "philanthropists who are sick of this activity" by drug companies that is "creating shortages and driving prices in an irrational fashion."...Intermountain is leading the collaboration with several other large hospital groups, Ascension, SSM Health and Trinity Health, in consultation with the U.S. Department of Veterans Affairs, to form a not-for-profit drug company. The groups together represent more than 450 U.S. hospitals.

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

Private investigators believe that the billionaire Toronto couple found dead at their home in December were murdered by multiple killers, a source with direct knowledge of the parallel probe into their mysterious deaths...The new information contradicts a widely circulated theory that Barry and Honey Sherman died as a result of a murder-suicide — a notion that is regarded as fiction by those who knew the Shermans well...Barry, 75, and Honey, 70, were found dead by a real estate agent in the basement of their Toronto mansion on Dec. 15. The source said their bodies were in an upright seated position on the floor near an indoor pool. Police deemed the deaths "suspicious" but have said little else since their investigation began...The Sherman family has hired a team of experts...Barry Sherman is the founder of Canadian pharmaceutical giant Apotex, and both he and his wife have been recognized internationally for their generous philanthropy.

The warning letter was sent late last month to Delta Laboratories of New South Wales, Australia, after the FDA put all of the company’s human and animal drugs and antibiotics on its import alerts list in September...According to the FDA, Delta didn’t fully investigate discrepancies, including signs that might have indicated microbial contamination and didn’t have the processes needed to assure products would remain stable during storage and through the expiration date. It also noted the quality assurance unit didn’t have the necessary authority to make sure those kinds of standards are met...Senior management stated that your firm has struggled with manufacturing this drug product, and that you were still conducting research to gain better product and process understanding. Although you acknowledged a lack of understanding to assure consistent quality, you still commercially distributed drug products to consumers...The agency strongly recommended that Delta hire a consultant if intends to continue to producing products for the U.S.

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.