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A Georgia pediatric cardiologist pleaded guilty...wrongfully disclosing information about his young patients to an Aegerion Pharmaceuticals Inc sales representative seeking to identify potential new users of an expensive cholesterol drug...Dr. Eduardo Montana...entered his plea in federal court...Montana pleaded guilty to a misdemeanor charge that he wrongfully disclosed patients’ individual identifiable health information. While he faces up to a year in prison, prosecutors have agreed to recommend a term of probation...According to prosecutors, after Aegerion in 2012 received regulatory approval to market Juxtapid for treating high cholesterol in adults with a rare genetic disease, the drugmaker promoted it for use by patients who lacked the condition...Montana...also disclosed information to a senior Aegerion executive promoting Juxtapid’s off-label uses and provided the sales representative the code to access his electronic medical record system...

With more than 700 orphan designation requests last year, the Food and Drug Administration...announced a new pilot program to make the request process more efficient...The pilot will include a new form intended to make the submission process easier for sponsors to complete orphan designation requests, and to make the process more efficient for FDA...FDA also released an on-line tutorial to guide sponsors through the submission process and Gottlieb noted there is a new inter-center consult process to streamline and standardize communications...In addition to the pilot, FDA vowed to eliminate the orphan drug designation backlog, and is planning a public meeting to discuss the scientific and regulatory issues related to cancer treatments that target a tumor’s genetic features rather than its location in the body...“We’ll also consider the appropriate application of orphan incentives to this new paradigm of drug development, and how we apply designations to these indications,”...

It’s been nearly two months since a law requiring doctors to take additional steps before writing prescriptions for opioids went into effect, though some of the questions and concerns raised by doctors about the law are only now just starting to be answered...A subcommittee formed specifically to address concerns related to the implementation of the law grappled with some of the areas of uncertainty at a recent meeting with the goal of ultimately clarifying the exact steps doctors must take when writing a prescription for painkillers and figuring out what punishment they should face should they fail to do so. But to what extent that clarification can or should be codified into state regulations will be up to the Board of Pharmacy, which will discuss the matter at a meeting early next month...Though the law, AB474, applies to any prescriber of opioids — from advanced practice registered nurses to dentists — most of the concerns about the law have come from medical doctors, who have lamented the extra time obtaining an informed consent and making a “good faith effort” to obtain a patient’s medical records. Some have even said they won’t write any more prescriptions for painkillers in response to the law and will direct patients instead to pain doctors...The Board of Medical Examiners is responsible for creating any disciplinary regulations they deem appropriate, but the law leaves any other clarifying regulations up to the Board of Pharmacy.

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

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

A massive lawsuit over the nation’s opioid crisis has largely ignored an influential group of companies in the prescription drug business...pharmacy benefit managers, these companies secretly make the rules that determine the availability of drugs, and how much patients must pay out of pocket to get them...a community in South Texas is calling PBMs into the fight, filing what its lawyers believe is the first case in the country to name these companies as defendants in a municipal opioid lawsuit...The complaint...was filed in January. And earlier this month it was absorbed into a larger lawsuit in Ohio that aggregates claims from cities and states across the country. That, in turn, could put these companies on the hook nationwide for settlement dollars and court orders meant to change the way the drug industry operates...The county’s suit includes claims against...Express Scripts, CVS Health, and OptumRx — along with two smaller companies that also operate in South Texas, Prime Therapeutics and Navitus Health Solutions...It also includes fraud, conspiracy, and racketeering charges against major drug manufacturers and wholesale distributors, as do many other complaints filed across the country. But Webb County’s case is unusual because of the legal claims and language directed at PBMs, entities the suit calls “the gatekeepers to the vast majority of opioid prescriptions filled in the United States.”

The generics sector has been looking to M&A as a way to combat the pricing pressure crushing top lines around the industry. But that strategy just got a whole lot less attractive...The Federal Trade Commission has suggested it will take steps that could force buyers to hold onto drugs they don't want, a shift that may even be holding up one big deal already...It’s not uncommon that when generics companies combine, the acquirer winds up with two versions of a complex drug—one on the market, and one still in development. In the past, a divestment of the pipeline candidate has solved the issue...Bruce Hoffman, acting director of the FTC’s Bureau of Competition, said earlier this month that the body will no longer allow companies to jettison complex drugs that are still in the works...That’s not a good development for wannabe buyers, as on-the-market drugs are much more valuable than prospects that may or may not ever see any sales. The move “has potential to change valuations and add risk to generic deals in the future,”...

The European Medicines Agency...announced that the Food and Drug Administration has confirmed the capabilities of regulators in the Czech Republic, Greece, Hungary and Romania to participate in a mutual recognition agreement focused on drug manufacturing inspections...Under the agreement, FDA can now rely on inspections conducted in 12 member states (the first eight were added in October 2017 – Austria, Croatia, France, Italy, Malta, Spain, Sweden and UK) to replace its own inspections. EMA said that plans are still on track for the mutual recognition agreement to be operational in all member states by 15 July 2019...Mutual benefits under the agreement for both EU and FDA authorities, which has been in place almost exactly a year, include: Avoiding duplicative inspections and reducing the administrative burden and costs, improving the use of inspection resources to focus on manufacturing sites of higher risk, and improving the ability to identify and address potential problems at manufacturing sites before they become a public health risk.

The Justice Department said...it will support local officials in hundreds of lawsuits against manufacturers and distributors of powerful opioid painkillers that are fueling the nation's drug abuse crisis...The move is part of a broader effort to more aggressively target prescription drugmakers for their role in the epidemic, Attorney General Jeff Sessions said. The Justice Department will file a statement of interest in the multidistrict lawsuit, arguing the federal government has borne substantial costs as a result of the crisis that claimed more than 64,000 lives in 2016...the Justice Department...which has also sought to crack down on black market drug peddlers and doctors who negligently prescribe...Targets of the lawsuits include drugmakers such as Allergan, Johnson & Johnson, and Purdue Pharma, and the three large drug distribution companies, Amerisource Bergen, Cardinal Health and McKesson. Drug distributors and manufacturers named in these and other lawsuits have said they don't believe litigation is the answer but have pledged to help solve the crisis.

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.