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A Johnson & Johnson subsidiary has agreed to pay $18 million to resolve charges of causing health care providers to submit false claims to Medicare and other federal health care programs, which then paid for a device that was illegally marketed...The settlement...comes...two days after a pair of former executives at...Acclarent, were found guilty of several misdemeanor charges of distributing a misbranded and adulterated device. A federal court...found the executives marketed the Stratus device for a use that was not approved by the Food and Drug Administration... Acclarent won FDA approval to market its Stratus device (Relieva Stratus Microflow Spacer) to be used only with saline to maintain sinus openings following surgery. But the feds alleged the company intended to market Stratus as a drug-delivery device for prescription corticosteroids and maintained the device was specifically designed and engineered for this use...The episode stems from a whistleblower lawsuit that was filed...by Melayna Lokosky, a former Acclarent sales rep...Her lawsuit described the steps that Acclarent had taken to promote the device and allegedly deceive physicians about its efficacy. She is expected to receive about $3.5 million from the settlement.

GlaxoSmithKline is recalling a "small" number of batches of its Bactroban antibiotic following a harsh rebuke from US regulators about contamination at a key plant. The move comes after the US Food and Drug Administration sent a stern warning letter late last month to the drug maker about a host of quality-control problems at the facility, which is located in...the United Kingdom...The FDA issued its missive...and found what it called "significant deviations" from good manufacturing practices...The FDA...also noted that the drug maker provided an inadequate response, despite having halted production of the antibiotic and recalling product from wholesalers last year...The letter is the latest attempt by the FDA to bolster the viability of the pharmaceutical supply chain amid a rash of quality-control gaffes. The agency has been attempting to crack down on manufacturers and ingredients suppliers — particularly in India and China — in response to various episodes that led to product recalls and import bans...

U.S. antitrust officials are poised to file lawsuits to block Anthem Inc.’s takeover of rival health-insurer Cigna Corp. and Aetna Inc.’s deal to buy Humana Inc...Justice Department officials, who are responsible for protecting competition, are concerned that the deals, which would transform the health-insurance industry by turning its five biggest companies into three, would harm customers, according to several people familiar with the situation. While the companies may offer to sell assets to gain approval for the deals, that’s unlikely to sway antitrust officials...The final decision on whether to sue to block the deals could come this week or next, another of the people said. The companies could settle a lawsuit before or after one is filed...

People naturally assume that the medicines prescribed by doctors are tightly regulated and have been approved by the Food and Drug Administration, but that’s not true. Loopholes in the regulations that set the standards for a practice called "drug compounding" have enabled dangerous products to injure and kill untold numbers of unsuspecting patients...FDA exempted compounding pharmacies from many of the manufacturing, labeling and other requirements other drugs are subject to...FDA does not require pharmacies to report adverse events associated with compounded drugs...the FDA has the authority to take action when compounding pharmacies violate the law and can act quickly if there is an "imminent hazard to public health," regulators have failed in several critical areas, including inspecting pharmacy records, enforcing quality standards and being able to identify the facility that made a particular drug...In order to create an acceptable risk-benefit paradigm for drug compounding, FDA needs to increase its scrutiny over compounding pharmacies. When a pharmacy is allowed to morph into a large-scale drug manufacturer without adequate oversight, it’s a matter of life and death.

The European Medicines Agency...recommended suspending the sale of dozens of generic medicines — many of which are sold by Novartis and Teva Pharmaceuticals — over concerns about "flawed" studies that were conducted by an Indian clinical research organization...The move comes three months after the US Food and Drug Administration alerted an untold number of drug makers of problems at the Semler Research Center...in Bangalore. An inspection...found "significant instances of misconduct and violations of federal regulations, including the substitution and manipulation of study subject samples."...the World Health Organization had issued a notice to Semler for the same reasons...regulators in each EU country will have to determine the extent to which specific medicines that were tested by Semler are critically needed before proceeding with suspensions. The EMA noted there is no evidence, to date, that any patients were harmed or that any of the drugs were not effective.

Britain's decision to leave the European Union threatens to undermine its position as a center for drug research and UK patients could fall behind others in Europe in getting access to new drugs, Roche's chief executive said..."If certain cutting edge innovative medicines do not become part of the standard of care in the UK, this hampers research and development," Roche CEO Severin Schwan said...Britain has a strong reputation for medical research but it is already a difficult market for launching expensive new drugs, such as the modern cancer treatments produced by Roche...

In a move that underscores the changing landscape of the pharmaceutical industry, the chief trade group has officially accepted one of the world’s largest generic drug makers into its ranks...Teva Pharmaceuticals became a member of the Pharmaceutical Research and Manufacturers of America, which has burnished its reputation on Capitol Hill and elsewhere as a staunch defender of brand-name companies...The decision to accept Teva...came as a surprise to some industry watchers, given the historical rivalry between brand-name and generic manufacturers...The move, however, isn’t all that unexpected, if only because the lines are beginning to blur.

Cate Douglass, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

U.S. antitrust officials on Thursday moved to block an unprecedented consolidation of the national health insurance market, filing suit against Anthem Inc's proposed purchase of Cigna Corp and Aetna Inc's planned acquisition of Humana Inc...The U.S. Department of Justice said the two mergers would reduce competition, raise prices for consumers and stifle innovation if the number of large, national insurers were to fall from five to three..."We will not hesitate to intervene. We will not shy away from complex cases," U.S. Attorney General Loretta Lynch told a news conference. "We will protect the interests of the American people."

A long-running court case filed in India by Roche seeking to prevent the use of label language by...Biocon and Mylan from claiming similarity to its aging breast cancer med Herceptin (trastuzumab) has turned tense--with both sides now seeking contempt-of-court charges...In the case of Roche...Biocon "violated a previous court order" temporarily barring any claims to similarity by using such language in a presentation at an international scientific conference on clinical trials with trastuzumab...At the same time, Biocon accused Roche of "disparaging statements" about the company as part of a campaign to block approval efforts for a trastuzumab biosimilar by Biocon in other countries...noting that Phase III trials are underway in the U.S. for a version of the breast cancer therapy...At the heart of the case is...that Biocon and...Mylan could not use the label biosimilar for versions of Roche's med.