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ood morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because — you guessed it — a new round of meetings, deadlines, and whatnot has returned. You knew this was coming, yes? So please join us for the mandatory cups of stimulation as we attempt to muddle through. Meanwhile, here are a few items of interest. Hope your day goes well and do keep us in mind for interesting tidbits …

An Express Scripts committee decides which drugs should be included on its recommended list of medicines for insurance coverage but refuses to disclose the identities of the committee members, the St. Louis Post-Dispatch writes. The pharmacy benefits manager says their identities are not disclosed to shield members from lobbying, but critics say the process should be more transparent.

Santa Cruz, Calif., became the latest local government to adopt an ordinance requiring the pharmaceutical industry to pay for a drug take-back program. The move means that nine counties or cities in California and the state of Washington have created programs that require drug makers to foot the bill, and environmental activists say that more are being proposed elsewhere, such as in Cook County, Ill.

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A report on new European legislation, which introduced rules for monitoring, identifying, and assessing adverse events, found that safety issues have been detected faster as a result, according to the European Medicines Agency. The rule created a Pharmacovigilance Risk Assessment Committee that helps coordinate activities of both the EMA and individual national regulators.

The US Food and Drug Administration determined that a drug tested in a clinical trial in France, which led to the death of a participant, has a “unique toxicity” and does not extend to others in the class. The FAAH inhibitor was being developed to treat chronic pain for people with cancer and other ailments. The study protocol was followed, but authorities partly blamed the drug maker and clinical research organization, and a criminal probe is under way.

Johnson & Johnson faces a batch of lawsuits in federal court in New Jersey claiming its blockbuster Levaquin antibiotic caused patients to suffer nerve damage, the New Jersey Law Journal reports. These represent a second wave of litigation, following hundreds of lawsuits linking its use to tendonitis and injured tendons. In May, the FDA warned of “disabling” side effects from Levaquin.

The FDA is holding meetings Monday to review the renewal of the Prescription Drug Use Fee Act and you can read the documents here.

Endo International is withdrawing its supplemental application seeking FDA approval for abuse-deterrent labeling for its Opana ER painkiller, Genetic Engineering & Biotechnology News says.

Novartis plans to invest $100 million to expand a production facility for monoclonal antibody drugs in France and boost capacity by 70 percent, according to PMLive.

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  • For anyone who thinks that the Clinton Foundation is only about foreign influence peddling the Levaquin saga reminds us it is much closer to home. Based upon their generous contributions to the CF and Obama’s campaign by former FDA Commissioner Dr Margaret Hamburg and her multimillionaire hedge fund manager husbamd Peter Brown Mrs. Clinton recommended to Obama that Hamburg be nominated for FDA commissioner. During Hamburg’s tenure Brown’s company, Renaissance Technologies held large positions in J&J and stood to lose significant sums when the Levaquin safety lawsuits first broke. Dr. Hamburg would not have any of that and so she did whatever she could to delay and obfuscate the inquiry while she and Brown profited handsomely on J&J stock. Alas but the chickens have come home to roost for poor Maggie and Peter, as they now find themselves at the center of a RICO lawsuit for the aforementioned actions.

    FDA commissioners have a nasty habit of getting in trouble on these things viz the former FDA boss Les Crawford, who should have stuck to being a veterinarian.

    Story of the racketeering and corruption lawsuit below. Apologies of Ed has previously reported on this.

    http://ahrp.org/former-fda-commissioner-charged-in-federal-racketeering-lawsuit/

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