- This Week in Managed Care: January 19, 2018 (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
- FDA Moving to Enhance Drug Approval Transparency, Gottlieb Says (ptcommunity.com)
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...
- FDA Delays Implementing Parts of ‘Intended Use’ Rule (raps.org)
Confusion and concerns over portions of a tobacco-related final rule have pushed the US Food and Drug Administration to delay implementation of the sections dealing with the types of evidence FDA may consider to determine how a manufacturer intends for its medical product to be used...This is a determination that can have significant implications for, among other things, how manufacturers communicate about and promote their products. How we determine intended use is an important issue that touches many fundamental aspects of the FDA’s work...FDA is seeking comments on the proposal to delay...effective date of the portion of the rule related to intended use of medical products, though the tobacco-related portions of the final rule will go into effect...At issue is how the initially proposed rule sought to remove a sentence, which FDA Law Blog last February called "the famous 'knowledge' sentence: 'But if a manufacturer knows, or has knowledge of facts that would give him notice, that a [drug or device] introduced into interstate commerce...is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a drug/device which accords with such other uses to which the article is to be put.'"...But the final rule did not remove the sentence and instead amended it with new language that angered industry groups, which called the move "a new and unsupported legal standard."
- Nevada doctors voice concerns over opioid law implementation (ktvn.com)
Nevada's new opioid prescription law is only days old but doctors already are worried about how it might be implemented...physicians, lawyers and others expressed concerns this week to the state medical and dental boards over draft disciplinary rules for doctors who write improper prescriptions for pain medications...Under the proposed rules, doctors who violate the new law five times would lose their licenses. The threshold on losing a license would be reduced to three violations by 2020...Several doctors who attended the meeting say the proposed rules don't specify the exact conduct that could lead to penalties or the loss of medical licenses...The doctors voiced concerns that they could be punished for relatively minor mistakes or employee errors.
- This Week in Managed Care: January 12, 2018 (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
- U.S. court invalidates patent on J&J cancer drug Zytiga (reuters.com)
A U.S. administrative court...invalidated a Johnson & Johnson patent on its blockbuster prostate cancer drug Zytiga, bringing rivals closer to selling generic versions...The Patent Trial and Appeal Board said a Johnson & Johnson patent describing a method of administering Zytiga should not have been granted because the process it described was obvious...The ruling was a victory for U.S. generic drug company Argentum Pharmaceuticals LLC, which had asked the board to invalidate the patent in hopes of bringing its own version to market...The patent is due to expire in 2027. Argentum and other generic drug makers have been blocked from launching their own versions of the cancer drug until its expiration date...Zytiga generated nearly $2.3 billion in sales for Johnson & Johnson in 2016.
- Flu-pocalypse? Why scientists are scrambling to make a ‘universal influenza vaccine’ (foxbusiness.com)
Flu season is already shaping up to be one of the worst seasons in over a decade, claiming the lives of nearly 20 children across the U.S. and 7% of senior deaths over the last month, according to the Centers for Disease Control and Prevention...One of the reasons for the massive outbreak this year...is that it involves the dreaded H3N2, a strain of the influenza that isn’t “very well-matched” with the current vaccines that are being distributed across the U.S...In the making of the vaccine as it was being grown in eggs...it got mutilated a bit, so it drifted away from a really, really good match...even in a very good year the influenza vaccine is only about 60% effective. And, the projection of how effective it is going to be against the H3N2 this year is about 30%...Sanofi, who is one of the largest makers of flu vaccines...has been “continuously focused on improving influenza vaccines” over the years...This is evident in our introduction of Fluzone High-Dose Influenza vaccine, the first and only flu vaccine shown to have superior efficacy against influenza compared to Fluzone vaccine in adults 65 and older, and our recent acquisition of Protein Sciences, which has developed a recombinant DNA technology system for the production of recombinant proteins. The company additionally has ongoing efforts to develop a broadly protective influenza vaccine that would be effective despite natural mutation of flu strains over time...
- Pharmacy Week in Review: January 19, 2018 (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.
- Wal-Mart launches program to safely dispose of unused opioids (reuters.com)
Wal-Mart Stores Inc...will provide customers filling prescriptions for opioids with a packet of powder that will help them dispose of leftover medication in order to help curb misuse and abuse...The company said patients filling any new class II opioid prescriptions at its pharmacies will receive a free packet of the product - called DisposeRx - when filling a new prescription. Patients with chronic Class II opioid prescriptions will be offered a free packet every six months...In order to safely dispose of opioids, patients would add warm water and the DisposeRx powder to their pill bottle, which then forms a biodegradable gel around the pills.
- Big pharma is getting ready to spend tax reform dollars on big deals (investing.com)
There's a lot of anticipation for big-ticket pharmaceutical mergers and acquisitions to take off in 2018...That's in large part because of the tax reform that passed in 2017, which frees up cash companies have overseas and lowers the corporate tax rate..."We'd love to use the cash to buy and partner to expand our pipeline...There's a potential for another round of change within the pharmaceutical sector, given there's this much money overseas and that's got a chance to be repatriated...Cash waiting to be used...It's something that's on company's radars...especially as they think of ways to use that repatriated cash. Other options besides acquiring companies with new medications in the works include share repurchasing programs, increasing dividends, and in some cases paying down debt...But the changes that tax reform brings doesn't necessarily mean there's going to be an across-the-board flood of new deals, since some major pharmaceutical companies aren't based in the US to begin with.