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The All of Us initiative, which will be launched on May 6, aims to compile detailed health profiles of 1 million Americans, with a special focus on communities historically underrepresented in biomedical research...The program, which began as a pilot last year, is the most ambitious attempt yet to compile health and behavioral data, as well as genetic sequencing, from a representative sample of the American population. It will collect electronic health records, survey data, and even information from its participants’ wearable fitness devices – with the goal of helping scientists better understand how to craft personalized treatments, seen by many as the future of biomedicine...

Co-payment assistance groups, created to help patients with the increasingly higher price of drugs...are under investigation by federal authorities for possibly skewing the cost of health care to favor drug companies...Critics of these groups, such as Patients for Affordable Drugs...say they drive up the cost of health care by masking the price of drugs and forcing higher costs on the insurance companies that pass them along to consumers and employers...The money to pay for the groups’ support of patients comes almost entirely from the drug companies themselves or other charities they fund...These groups are a marketing arm of pharma, and the fact that patients are caught in the middle...The U.S. attorney in Massachusetts and the Health and Human Services inspector general have been investigating this insurance co-payment assistance for more than three years...It's illegal under federal "anti-kickback" law for drug companies to pay patients' Medicare drug co-pays, and any patient group that covers these co-pays can't steer consumers to their pharmaceutical donors' drugs...the Justice Department reached a settlement agreement with drugmaker United Therapeutics...The government accused UT of paying kickbacks to Medicare patients through a charity, Caring Voice Coalition, "that held itself out as an independent charitable foundation." The drugmaker paid $210 million to resolve the allegations, and the Justice Department rescinded an advisory opinion it issued CVC because the group "allowed its drug company donors to funnel money through CVC in potentially illegal ways that served the drug companies’ financial interests."

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

Branded drugmakers have said "no fair" to the U.S. Patent and Trademark Office's inter partes review system almost since its inception seven years ago. One reason? "It's unconstitutional," the companies contend...The Supreme Court...disagreed...In a 7-2 vote, the U.S. High Court held that the system is constitutional. It doesn't violate Article III of the Constitution, which gives the judicial branch alone the power to decide legal arguments. Nor does it violate the Seventh Amendment, the right to a trial by jury...It's a limited ruling specific to the issues in this particular case, Oil States Energy Services v. Greene’s Energy Group...Justices John Roberts and Neil Gorsuch dissented, saying only an independent judge—not a political appointee at the PTO—should be able to revoke patents, which they equated with personal property such as a home or a farm...PhRMA...said the "narrowly tailored decision" found only that IPRs are constitutional, not "efficient or fair." The arguments and a...ruling in another case—SAS Institute v. Iancu—mean it's "clear there are problems with the IPR process that need to be addressed,"...

Laura Joszt, 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 text for the Seat Agreement between the agency and the Netherlands has been finalized. The agreement describes how EMA will be treated by the Dutch government when EMA relocates to Amsterdam. The agency also announced that the Dutch Council of Ministers had agreed to sign the agreement...The agreement will be signed after the legislative process on the relocation is completed by the European Council, the European Parliament, and the European Commission...According to EMA, the Seat Agreement allows EMA to function independently in the Netherlands. Similar agreements apply to other EU agencies located in the Netherlands...As this transition needs to be supported by EMA staff in the Netherlands, a timely signing of the agreement would make sure that EMA staff and their families have clarity on their treatment and can settle in the Netherlands...

...FDA’s Center for Drug Evaluation and Research released its second annual Drug Safety Priorities report, which details drug safety initiatives carried out by CDER and FDA. The report highlights drug safety program milestones and gives an update on goals achieved in 2017. Efforts by FDA to ensure drug safety science, surveillance, and oversight are discussed...Detailed in the report are the agency’s efforts on pharmacovigilance, medication errors, and risk management...The report also goes into detail about the agency’s views on how real-world evidence can advance drug safety. An update on the agency’s efforts to combat the opioid crises is also provided...

The head of the Centers for Medicare and Medicaid Services said...it's time that health care catches up with other industries when it comes to providing consumers greater transparency about prices up front and easier access to their records and health data once they have received care..."We know that any other place in the economy you can know what things are going cost. Somehow in health care it's a big mystery," said CMS administrator Seema Verma...CMS issued a series of new proposals aimed at promoting greater interoperability of digital health-care records. They include forcing hospitals to post their prices online, and pushing them to transfer patients' discharge records to their doctors electronically, even if the doctors are not part of the same health system...Doctors who treat Medicare patients are already required to write prescriptions electronically. CMS now wants them to also make it easier for patients to access those records digitally...The administration's 2019 budget outline includes a proposal to give Medicare Part D plans for seniors more power to negotiate lower prices from manufacturers, and it initiates a pilot program that would allow state Medicaid programs to test drug formularies aimed getting more competitive prices...

It's not often that one misguided phone call—and a subsequent cover-up—costs a company hundreds of millions, but that's exactly what happened in a hepatitis C patent dispute between Merck & Co. and Gilead Sciences...an appeals court confirmed that decision, agreeing with a lower court judge that Merck isn't entitled to a hefty $200 million jury award—precisely because its lawyer's misbehavior "infects the entire lawsuit."...a federal jury in California had awarded $200 million to Merck, the judge in the case, Beth Labson Freeman, struck down that verdict because she found a "pervasive pattern of misconduct" by Merck...A former Merck scientist and patent attorney, Phillipe Durette, learned of a Pharmasset hep C drug structure during a 2003 conference call between the companies, which were discussing potential partnership arrangements. Durette then altered a Merck patent application, the court found...Dr. Durette's participation in that conference call violated a "firewall" the companies had set up to ensure that participants weren't involved in patent applications...

The Royal College of Physicians of London has joined calls for an end to criminal sanctions against people who take drugs such as heroin, cocaine, and cannabis for non-medical reasons...The college now endorses the stance of the Faculty of Public Health and the Royal Society for Public Health. In a 2016 report the RSPH concluded that the “war on drugs” fails to deter drug misuse but instead deters people with drug use disorders from seeking treatment and inhibits harm reduction efforts...Jane Dacre, president of the Royal College of Physicians, told The BMJ, “The criminal justice system is not the place to address the often complex needs of people addicted to drugs. (subscription required)