Author: Peter

State governments have stepped up their oversight of drug compounding in recent years, yet resource limitations may be hamstringing regulators from even more thorough inspections of traditional pharmacies, according to a new report...In 2015, the District of Columbia and 26 states required routine inspections of compounding pharmacies at least once a year. But by 2017, the number had fallen to 22 states plus the nation's capital...Many states have taken significant steps to better regulate drug compounding since the disastrous meningitis outbreak that came as a result of the New England Compounding Center's adulterated steroids...32 state boards of pharmacy require traditional pharmacies that compound sterile drugs to be in complete alignment with quality standards set forth in the U.S. Pharmaceutical Convention General Chapter. Another 11 states have provisions in place that they've determined are as strong — if not stronger — as the General Chapter's guidance...Issues have arisen despite that progress...Pew's research identified more than 50 reported or potential compounding errors from 2001 to 2017. The errors were linked to 1,227 adverse events, including 99 deaths — and those figures are likely low estimates, according to the organization.

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

...states across the country are moving to block “gag clauses” that prohibit pharmacists from telling customers that they could save money by paying cash for prescription drugs rather than using their health insurance...Many pharmacists have expressed frustration about such provisions in their contracts with the powerful companies that manage drug benefits for insurers and employers. The clauses force the pharmacists to remain silent...“the pharmacist cannot volunteer the fact that a medicine is less expensive if you pay the cash price and we don’t run it through your health plan.”...In North Dakota, a new law explicitly bans gag orders. It says that a pharmacy or pharmacist may provide information that “may include the cost and clinical efficacy of a more affordable alternative drug if one is available.”...also says that a pharmacy benefit manager or insurer may not charge a co-payment that exceeds the actual cost of a medication...the Pharmaceutical Care Management Association, has filed suit in federal court to block the North Dakota law, saying it imposes “onerous new restrictions on pharmacy benefit managers.”

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.”

A coalition of 20 states sued the federal government...over Obamacare, claiming the law was no longer constitutional after the repeal last year of its requirement that people have health insurance or pay a fine...Led by Texas Attorney General Ken Paxton and Wisconsin Attorney General Brad Schimel, the lawsuit said that without the individual mandate, which was eliminated as part of the Republican tax law...Obamacare was unlawful..."The U.S. Supreme Court already admitted that an individual mandate without a tax penalty is unconstitutional," Paxton said in a statement. "With no remaining legitimate basis for the law, it is time that Americans are finally free from the stranglehold of Obamacare, once and for all," ....

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.

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.

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...

Drugmakers are racing to scoop up patient health records and strike deals with technology companies as big data analytics start to unlock a trove of information about how medicines perform in the real world...Studying such real-world evidence offers manufacturers a powerful tool to prove the value of their drugs...Real-world evidence involves collecting data outside traditional randomized clinical trials, the current gold standard for judging medicines, and interest in the field is ballooning...The ability to capture the experience of real-world patients, who represent a wider sample of society than the relatively narrow selection enrolled into traditional trials, is increasingly useful as medicine becomes more personalized...It’s getting more expensive to do traditional clinical trial research, so industry is looking at ways it can achieve similar goals using routinely collected data...The thing that has made all this possible is the increasing digitization of health records...Food and Drug Administration...believes more widespread use of real-world evidence (RWE) could cut drug development costs and help doctors make better medical choices...Under the 21st Century Cures Act, the FDA has been directed to evaluate the expanded use of RWE...As the breadth and reliability of RWE increases, so do opportunities for FDA to also make use of this information...

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,”...