Trump urges Justice Department to target opioid makers with a ‘major lawsuit’

Months ago, the Department of Justice backed the hundreds of lawsuits that accuse drugmakers and distributors of their alleged contribution to the nation’s opioid epidemic. Now, President Donald Trump is asking Attorney General Jeff Sessions to take another step, to bring “a major lawsuit” of its own.

During a cabinet meeting on Thursday, Trump asked Sessions to bring “a major lawsuit” against opioid makers “that are really sending opioids at a level that it shouldn’t be happening,” according to a conference transcript from the White House.

Trump said that instead of joining existing litigation brought against the companies, he wanted the attorney general to bring a separate federal lawsuit, and that he’d be “very, very firm on that.” Sessions, appearing to concur with the president, said his department is “looking at various, different legal avenues to go after abusive companies.”

In a statement sent to FiercePharma, Purdue Pharma, which is under scrutiny for its marketing of OxyContin, said it “shares the president’s concern about the opioid crisis,” and that it “is committed to working collaboratively with those affected by this public health crisis on meaningful solutions to help stem the tide of opioid-related overdose deaths.”

The request coincided with a new proposal the Justice Department and the Drug Enforcement Administration jointly unveiled to fight opioid abuse. The agencies propose to cut production quotas for the six most frequently misused opioids by an average 10% next year. Those six opioids are oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine and fentanyl.

It also came a week after the DOJ reached an agreement in principle to settle a federal probe into Insys Therapeutics’ sales practices of Subsys, an under-the-tongue spray version of fentanyl. The company is paying $150 million to wrap up charges that it engaged in off-label marketing and paid kickbacks to doctors for prescriptions.

(cr: FiercePharma)


GlaxoSmithKline whacks 165 jobs as it closes skincare products plant in Ireland

The future of GlaxoSmithKline’s Sligo plant in Ireland has been uncertain for many years. Now it’s settled: The U.K. company will close the plant and lay off its 165 workers over the next three years.

In an announcement to employees on Thursday that was shared by the company, it said the plant had improved its cost efficiency over the years but that sales of its skincare products have not met projected demand. GSK called the “current business model unsustainable.”

Glaxo considered alternative uses for the plant but said they were unworkable “without significant further investment.”

“We informed employees at our skincare manufacturing site in Sligo of a proposal to close the site. Under this proposal, which affects 165 employees, we would phase down production over three years, before decommissioning the site in the latter part of 2021,” Glaxo said in its announcement.



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Tobacco products

FDA takes steps to improve efficiency, transparency of tobacco product application review process as part of comprehensive framework to reduce the disease and death related to tobacco products.

“We’re taking additional steps to improve the efficiency and effectiveness of our review process for tobacco product applications, as part of the commitments we made when we unveiled our comprehensive framework last summer,” said FDA Commissioner Scott Gottlieb, M.D.“We’re committing to provide additional information about the FDA’s science-based review decisions to manufacturers who’ve received a decision from the FDA that their product has not met the standards for authorization under the agency’s pathway for demonstrating substantial equivalence to a predicate tobacco product.  (See more details on FDA’s website)


Roche’s Genentech has become serial tax appealer in California

What is the difference between $33 billion and $19 billion? If you are Genentech, it is $190 million in taxes and sometimes years of tax litigation.

Genentech is the second largest taxpayer in California’s San Mateo County behind United Airlines, which also has its headquarters there. But according to a review of tax records by the San Francisco Chronicle, the unit of Roche has become a serial tax appealer, more aggressively fighting tax bills than any other company there.

Genentech has 653 pending tax cases in the county where much of its sprawling campus is located. Many of those, some dating to 2000, involve disagreements over whether depreciation on its manufacturing and lab equipment was figured accurately. Genentech does much of its biologics manufacturing there.  (See more details on FiercePharma)


China targets Cosentyx, Shingrix and Luxturna and 45 other drugs for priority approval

Hey, Big Pharma stars: China wants you. Aiming to speed new drugs to market, China just came up with a target list of 48 treatments greenlighted abroad, including some of the industry’s biggest names.The idea? Persuade their makers to apply for Chinese approval based on foreign trial data.

The list of “clinically urgently needed new drugs” was developed by experts convened by China’s State Drug Administration. The group mainly considered medications already approved in the U.S., EU and Japan, but not yet marketed in China.


According to the agency’s Center for Drug Evaluation, the country is in urgent need of these drugs to fight rare diseases or life-threatening conditions, because no effective treatment exists in China or because they’ve shown clear advantages in clinical studies.

See more details on FiercePharma


Janssen, Bayer to close South Korean plants due to limited demand

Another drugmaker will close up manufacturing in South Korea. Janssen Korea will shutter its Hyangnam plant in Hwaseong, South Korea, by 2021, laying off an undetermined number of workers.

According to a Janssen Korea spokesperson cited by The Korea Times, the closure is a strategic decision made over limited needs for solid-dosage drugs.

“Our manufacturing network for solid dosage forms was found to have significant excess capacity, and our future pipeline is unlikely to drive significant volume upside for the solids, due to an ongoing shift of production to cancer drugs and immune booster injections,” the spokesperson told the Korean newspaper.

The Janssen announcement follows one by Bayer, which in May said it would close a plant in Anseong that manufactures contrast media, according to Business Korea. It now intends to stop operations at the plant by the end of the year as it seeks a buyer.