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Europe's medicines regulator has recommended the suspension of more than 300 generic drug approvals and drug applications due to "unreliable" tests conducted by Indian contract research firm Micro Therapeutic Research Labs...The decision, announced by the European Medicines Agency...is the latest blow for India's drug-testing industry, which has run into a series of problems with international regulators in recent years...The inspections identified several concerns at the company’s sites regarding misrepresentation of study data and deficiencies in documentation and data handling...there is no evidence of harm or lack of effectiveness of the medicines, which include generic versions of many common prescription pharmaceuticals, including blood pressure tablets and painkillers...Drug tests carried out at Indian contract research organizations have been key in getting a huge array of generic medicines approved for sale around the world over many years…In the wake of such trial data scandals, many large drugmakers have been shifting more critical trials back to the United States and Europe over the last three years...

Biogen's defense of its blockbuster multiple sclerosis treatment Tecfidera (dimethyl fumarate) got a lift...after the U.S. Patent Trial and Appeal Board rejected a patent challenge by a group affiliated with hedge fund manager Kyle Bass...The...Board upheld Biogen's '514 patent on the 480 mg dose of Tecfidera, boosting the chances Biogen will be able to maintain patent protection on the top-selling drug for longer...Despite the positive development, Biogen hasn't fully put to rest the patent challenges surrounding Tecfidera. So-called interference proceedings between the company and Forward Pharma are still ongoing at the Patent Trial and Appeal Board, which could force Biogen to pay Forward royalties on sales of Tecfidera.

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

A multi-agency effort to improve community health in Southern Nevada is making progress…Officials involved in the Community Health Improvement Plan detailed several areas of progress for the initiative…

• A program that will switch 911 emergency callers with low-priority health issues to a hotline manned by an on-call nurse is expected to start in July…
• The district’s mobile health clinics are on course to expand their presence in areas with a dearth of health care facilities and services starting in June.
• An effort to target obesity and tobacco usage by promoting active lifestyles and healthy eating has gained momentum...an app called Neon to Nature, which promotes using walking and biking trails, have exceeded goals, and officials have success in enrolling students in smoking prevention programs and getting schools to participate in fitness programs...

HHS again has delayed enforcement of a final rule that would penalize drugmakers that deliberately overcharge providers for drugs purchased under the 340B drug discount program...The federal 340B program requires drug manufacturers to provide outpatient drugs to eligible health care providers at discounts ranging from 20 to 50 percent...the program has come under scrutiny, with some questioning the amount of charity care participating hospitals are providing...Under the final rule...drugmakers that "knowingly and intentionally" overcharge providers for drugs purchased through the program will face a fine of up to $5,000 per offense. The drugmakers also have to repay the overcharge...The rule took effect on Feb. 28 and was scheduled to be enforced beginning April 1...HHS again delays enforcement date...HHS in an interim rule published Monday in the Federal Register again delayed the rule's enforcement date, this time to May 22.

Venezuelan President Nicolas Maduro said on Friday he has asked the United Nations to help the South American nation alleviate medicine shortages, which have become increasingly severe as the oil-producing nation's economic crisis accelerates...Triple digit inflation and a decaying socialist economic model have left medications ranging from simple anti-inflammatory drugs to chemotherapy medication out of reach for most Venezuelans...The Venezuelan Pharmaceuticals Federation estimates some 85 percent of drugs are unavailable to the country's citizens...Maduro often blames the deteriorating economy and widespread shortages of goods on an "economic war" led by opposition politicians with the help of the United States...Critics say the problems are the result of dysfunctional price and currency controls that have decimated private industry.

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

For years, the FDA’s adverse events system has been derided because of its largely voluntary nature — only drug companies, not doctors or patients, are required to report problems. As a result, the system likely only was capturing a small percentage of cases...In recent years, the number of reports filed has been multiplying, prompting more independent researchers and drug companies to use the data as a way to detect safety problems...The surge in reports could indicate a growing number of harmed patients or more vigilant reporting of adverse events, a goal of the FDA. Experts say both likely play a role...Twelve years ago, there were 206,000 reports of side effects from medications filed with the FDA — complaints as frivolous as flatulence, as serious as death...By 2015, the most recent full year of data, the number had grown to 1.2 million...

China's FDA published a slate of suggested amendments to its foreign drug registration rules...which could dramatically revamp the country’s pharmaceutical market landscape by eliminating hurdles that slow approvals of Western drugs. Pharma companies quickly hailed the changes...the new rules would allow foreign drugmakers to file for a new drug approval using data from international, multicenter trials, so long as those trials include China as a study site. Translation: No China-specific trial applications would be required for those foreign drugs...When finalized and implemented, these policies will encourage biopharmaceutical innovation and accelerate the approval process for new medicines...They will also pave the way for China's integration into the system for multiregional clinical trials that undergirds global drug development...

The cost to healthcare companies for U.S. regulatory review of their products, including drugs and medical devices, would more than double under the Trump administration's proposed 2018 budget…over $2 billion in fees to be collected by the U.S. Food and Drug Administration from industry, twice as much as in 2017...it also offered measures that would help speed up the approval process for new drugs and other products...The FDA has been charging companies to review their products since 1992. Most of the user fees collected are for prescription drugs - around $866 million estimated in 2017 - and generic drugs - around $324 million...The budget does not say if the fee increases would be evenly spread or directed in a particular area. The budget did not provide specifics on what measures to speed up approvals might include...