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FDA...inspecting the plant of the Chinese API maker after learning its valsartan contained an impurity that is a suspected carcinogen...this was the first visit to list observations that strike at the heart of the manufacturing changes made by Zhejiang Huahai Pharmaceutical that are suspected of producing the impurity that resulted in a global recall of its valsartan...In an 11-observation, highly redacted Form 483 issued posted today, the FDA berated the management for making the process changes without thoroughly testing them...Huahai did not conduct and document a formal risk assessment for the change "to evaluate the potential impact of proposed changes on the quality of the intermediates or the final API for this critical change to your validated manufacturing process..."

Almost half of all European-registered clinical trials - in which scientists test drug treatments, interventions or therapies in humans - have breached EU rules by failing to report results...The analysis also found that while most major pharmaceutical companies are coming close to complying with EU reporting rules for trials in people, most major academic institutes are not...European Union guidelines say that funders of clinical trials must ensure all studies entered on the EU Clinical Trials Register since 2004 have posted results there within a year of concluding...Advocates for transparency in science say enforcing the rule is necessary to ensure researchers do not bury results they consider unfavorable...We cannot make informed choices about which treatments work best, as doctors and patients, unless all results are reported...

The FDA's latest round of testing has revealed an additional impurity, N-nitrosodiethylamine (NDEA) in three lots of Torrent Pharmaceuticals' recalled valsartan products. NDEA is a known animal carcinogen and a suspected human carcinogen...The source of the impurity was the valsartan active pharmaceutical ingredient from Zhejiang Huahai Pharmaceuticals. Not all products made from Zhejiang Huahai's valsartan contain the impurity, however...More than half of valsartan products are now under recall and FDA said last month more are likely...The story has now escalated. Once the FDA and EMA learned that Zhejiang Huahai discovered an additional impurity, NDEA, the authorities retested all valsartan API and products. Like NMDA, NDEA appears to be formed as a result of a specific sequence of steps in manufacturing.

A doctor has been disciplined by Nevada state pharmacy regulators after he was accused of improperly looking up prescription records of the dead gunman in last October's mass shooting in Las Vegas...Attorney E. Brent Bryson said Thursday that Dr. Ivan Goldsmith has to pay $26,000 in fines and attorney fees but keeps his license to prescribe medicines if he completes a year of probation...Goldsmith was accused of improperly looking up gunman Stephen Paddock's patient profile and disclosing to the Las Vegas Review-Journal that Paddock had been prescribed diazepam, an anti-anxiety drug better known as Valium.

California’s insurance regulator is suing AbbVie Inc., alleging that the pharmaceutical giant gave illegal kickbacks to health-care providers in order to keep patients on its blockbuster rheumatoid arthritis drug Humira...The company “engaged in a far-reaching scheme including both classic kickbacks -- cash, meals, drinks, gifts, trips, and patient referrals -- and more sophisticated ones -- free and valuable professional goods and services to physicians to induce and reward Humira prescriptions...AbbVie paid for registered nurses that it called ambassadors to help doctors with patients who were taking Humira. While the nurses were represented to patients as an extension of the doctor’s office, they were trained to tout the drug while downplaying its risks...The allegations “are without merit,”...The company complies with state and federal laws governing interactions between health-care providers and patients...Its services help patients and “in no way replace or interfere with interactions between patients and their health-care providers...

The Reno and Sparks Chamber of Commerce announced...will begin offering an association health plan to its small business members in partnership with Prominence Health Plan, following in the footsteps of four other chambers of commerce in Southern Nevada that unveiled similar plans with other insurance companies last month...Small businesses that are members of the chamber will be able to purchase medical coverage through Prominence and dental, vision and life insurance through Kansas City Life...The Las Vegas Metro Chamber of Commerce and the Clark County Health Plan Association, a partnership of three smaller Southern Nevada chambers, each announced plans last month to begin offering association health plans to their members in the wake of a rule released by the Department of Labor in June loosening the rules on such plans. The new rule exempts association health plans from providing the essential health benefits required under the Affordable Care Act, eliminates restrictions based on geography and allows companies in different industries in the same region to provide coverage together...

Nevada Medicaid will reverse its decision to require prior authorization for mental health services after providers and patients raised concerns that the policy change could delay treatment...The Division of Health Care Financing and Policy will hold a public hearing in October to rescind prior authorization requirements for psychotherapy and neurotherapy services, including “talk therapy” and biofeedback. Medicaid behavioral health supervisor Alexis Tucey announced the change Tuesday at a public workshop in Las Vegas...The policy approved in August will still take effect Oct. 1, giving providers five sessions with a patient before they are required to submit additional documentation to the state Medicaid office...The change came as a relief to providers who were worried they would have to stop seeing patients while waiting for approval of additional sessions or risk denial of payment by continuing to see clients to avoid disruption in care...

The Department of Justice has given the green light to insurance giant Cigna Corp.'s planned $67 billion acquisition of pharmacy benefit manager Express Scripts...The move terminates the applicable waiting period..The transaction still remains subject to certain state regulatory approvals and filings, including clearances from certain departments of insurance...Cigna and Express Scripts have obtained clearances from departments of insurance in 16 states. The companies are working with regulators in the remaining jurisdictions to obtain clearance for the merger...

Nevada's prisons pharmacy chief says she ordered and obtained lethal injection drugs this year despite knowing drug manufacturers didn't want their products used for executions...Linda Fox's drug purchases allowed Nevada to plan its first execution since 2006 using a never-before-tried three-drug combination...She testified...that she didn't specify the end use when she obtained medications from a third-party supplier, not the drug makers...Fox was pressed by lawyers representing drug companies a day after the state's prisons chief provided sworn testimony about having trouble obtaining drugs for executions...

European medicines regulators have issued a notice that an ingredient for a generic brain cancer drug made in China does not meet manufacturing standards, after inspectors were refused entry to a factory run by Jiangsu Yew Pharmaceutical Co. Ltd...is the latest example of regulatory problems with bulk pharmaceutical substances manufactured in China...Jiangsu Yew refused to allow a site inspection by Hungarian officials, acting on behalf of Europe’s drug regulatory system. The rebuttal led the EU authorities to determine that its supplies of temozolomide, used to treat brain tumors, did not comply with good manufacturing standards...The company’s export director Henry Yang told Reuters via email that the inspection was refused because Jiangsu Yew only made an intermediate product, rather than an active pharmaceutical ingredient, so an audit was not required.