Category:

The raging dispute between Anthem...and Express Scripts...is winning notice because the companies are battling over billions of dollars in prescription drug costs. Specifically, Anthem contends Express Scripts, which manages prescription drug benefits for health plans, failed to pass along rebates negotiated with drug makers...The battle, which is described in a lawsuit filed in federal court in New York...Anthem claims emphatically that Express Scripts has not been transparent because a third-party consultant conducted an audit and found the insurer was overpaying Express Scripts by about $3 billion annually...Anthem is seeking $15 billion in damages and wants out of its contract with Express Scripts...The outcome "could have far-reaching effects" on pharmacy benefits management..."The lawsuit challenges a fundamental aspect of PBM-insurer relationships: the value of a PBM’s negotiating power" with drug makers. The dispute could "embolden other (Express Scripts) clients to do the same" thing and claim they are not receiving rebates to which they are entitled...Another industry watcher...suggests that Anthem may have an additional motive for its lawsuit beyond recovering money. Anthem plans to merge with Cigna...which happens to have its own pharmacy benefits manager..."Anthem likely wants to bring its PBM function back in house as part of a combined Anthem-Cigna company,"..."Perhaps Anthem’s dispute with Express Scripts is in part a way to convince the FTC to approve the Anthem-Cigna merger because it would increase competition in the PBM market."...

An Illinois-based psychiatrist has been sentenced to 9 months in federal prison and ordered to pay nearly $600,000 for accepting hundreds of thousands of dollars in pharmaceutical industry kickbacks...Michael J. Reinstein, MD, was convicted of accepting payments from industry in the form of consulting fees, entertainment, and all-expense-paid vacations in exchange for prescribing and promoting first the brand-name version and then the generic version of the antipsychotic clozapine to thousands of indigent elderly patients in Chicago-area nursing homes and hospitals...In addition to the 9-month sentence, ordered by US District Judge Sharon Johnson Coleman, Dr Reinstein was ordered to forfeit $592,000 and perform 120 hours of community service following his release from federal prison...Dr Reinstein fully cooperated with the government in its ongoing investigation into healthcare practices in the Chicago area...In recognition of this cooperation...sentence was reduced to 9 months in a federal prison.

Horizon Pharma has already come under fire from federal prosecutors and payers for its patient assistance programs and questionable ties to specialty pharmacies. Now the company is being slapped with the inevitable securities lawsuit in a U.S. district court over related allegations...New York-based law firm...filed a suit in the...Southern District of New York on behalf of people who bought stock...The firm claims that Horizon "made materially false and misleading statements to investors" and hid unsavory information about its patient assistance programs...Lawyers are seeking damages on behalf of defendants...Horizon set up its Prescriptions Made Easy program to "artificially inflate" prices for similar retail drugs, which negatively impacted sales...Horizon released financial statements that were materially false and misleading...opening up the company to more regulatory pushback...When the true details entered the market about the company's patient assistance programs...the price of the stock dropped sharply and investors suffered damages…

A skirmish over drug pricing escalated...when the pharmaceutical industry filed a lawsuit to prevent consumer activists in Ohio from pursuing a ballot measure designed to lower the cost of medicines...The Pharmaceutical Research and Manufacturers of America contends that the activists failed to legally obtain the signatures needed to get their measure on the state ballot. Known as the Ohio Drug Price Relief Act, the proposal would require the state to pay no more for medicines than the Department of Veterans Affairs...The ballot measure is one of a growing number of maneuvers around the country to combat rising prescription drug prices. A similar measure recently qualified for the ballot in California, despite opposition from the pharmaceutical industry...The lawsuit in Ohio follows weeks of jockeying between the activists, the trade group, and elected officials over the process for gathering and approving signatures...While the ongoing dispute focuses on the technical procedures involved in winning space on the state ballot, the clash is really about the cost of medicines...pharmaceutical industry...strongly opposes any efforts to impose price caps or encourage negotiations over prices...

...Anthem Inc said it had sued pharmacy benefit manager Express Scripts Holding Co to recover damages from drug pricing it believes was too high...latest development in a months-long dispute over Anthem's contract with Express Scripts...The lawsuit also seeks to recover damages from operational issues and for a declaration of Anthem's right to terminate its contract with Express Scripts…Anthem, which has been seeking $3 billion in annual cost savings through a repricing provision in its 10-year contract with Express Scripts, said it had not yet decided whether to end the contract...The latest news has taken a very unhealthy turn and we see it unlikely that Anthem renews its contract with Express Scripts past 2019, and is likely to leave sooner to the extent it can manage the transition for consumers smoothly...Express Scripts...said in a statement that it believed the lawsuit to be without merit. The company has consistently acted in good faith and in accordance with the terms of its agreement with Anthem…

The charity Medicins Sans Frontieres has formally opposed U.S. firm Pfizer Inc's application for an Indian patent on a highly effective pneumonia vaccine, saying it could deprive many developing nations of cheaper copies of the drug...Some of the world's poorest countries and medical charities such as Medecins Sans Frontieres depend on India's robust pharmaceutical industry to make cheaper forms of drugs and vaccines developed by big Western pharmaceutical companies...If India granted Pfizer a patent on its Prevnar 13 pneumonia vaccine, Indian firms would not be able to produce affordable versions of it for domestic use or exports...To make sure children everywhere can be protected from deadly pneumonia, other companies need to enter the market to supply this vaccine for a much lower price than what Pfizer charges...

 The maker of a prescription fish-oil drug says it has reached a legal settlement that will allow it to promote unapproved uses of its drug for lowering fat levels...The closely watched case between Amarin and the Food and Drug Administration could strengthen the drug industry's hand in the ongoing debate over promoting drugs for uses that have not been declared safe and effective by regulators...FDA said...the settlement is "specific to this particular case and situation," and did not mark a new legal precedent...pharmaceutical experts said companies would likely pursue more aggressive legal action against FDA, in light of the settlement...We would expect companies throughout the country to ask courts to provide the same legal reasoning...Amarin won a surprise victory over the FDA when a U.S. District Court judge ruled that the company had a First Amendment right to distribute journal articles about unapproved indications for Vascepa (icosapent)...Drugmakers are not allowed to advertise drugs for "off-label" uses, or those that have not been cleared by the FDA as safe and effective. But companies' ability to distribute independent materials about their drugs — such as medical journal articles — has been subject to years of legal debate centering around the limits of "commercial speech."

Amgen Inc. won a legal victory over Regeneron Pharmaceuticals Inc. in an intellectual property battle over their cholesterol-reducing drugs. Regeneron said it would appeal the decision...A federal jury...rejected Regeneron’s challenges and ruled in Amgen’s favor that two of its patents on its drug, Repatha (evolocumab), were valid...Sanofi and Regeneron said after the verdict that they plan to appeal, reiterating their position that Amgen’s patent claims are invalid. They had claimed that Amgen hasn’t fulfilled requirements to describe clearly what it had invented in a way that others could understand...Amgen...is thankful that the jury weighed the evidence carefully and recognized the validity of Amgen’s patents on Repatha...With the decision, Regeneron and Sanofi are liable for royalties...The companies may reach a settlement with Amgen...

An Indian court on Tuesday granted interim injunction to U.S. drugmaker Abbott's India unit, and domestic companies Glenmark Pharmaceuticals and Macleods Pharmaceuticals, on the prohibition on sale of several combination drugs...India banned 344 drug combinations over the weekend, including Abbott's codeine-based cough syrup, after a government panel of experts found they had "no therapeutic justification"...The judge in the Delhi High court granted an interim stay to the pharmaceutical companies and said regulators should take "no coercive steps" against them. The case will now be heard on March 21.

The whistleblower who exposed quality problems at one of India’s largest generic drug makers is now taking on the Indian government...Dinesh Thakur, whose work helped US authorities obtain a $500 million fine from Ranbaxy Laboratories three years ago, wants to force the Indian government to follow safety laws and also create one central regulator for the entire country...He claims the country’s fractured system of separate regulators for 37 states and territories, not only leads to inconsistent and spotty oversight, but also violates the constitution...A hearing at the Indian Supreme Court is scheduled...