Local firms face actions related to opioids

Endo Pharmaceuticals could have Opana ER taken off market; more West Virginia communities sue AmerisourceBergen

Endo Pharmaceuticals could have Opana ER taken off the market; AmerisourceBergen faces more lawsuits.

EAST WHITELAND » A second Chester County company is now embroiled in the nation’s opioid crisis.

Committees of the U.S. Food and Drug Administration recently found the benefits of Endo Pharmaceuticals’ reformulated Opana opioid no longer outweigh the risk it poses for misuse.

The Drug Safety Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees voted 18 to eight, with one abstention, on the no-confidence motion.

The FDA typically follows the recommendations of its panels but is not obliged to do so. As a result of the committee votes, the FDA could choose to change the product’s labeling, restrict prescribing it or remove it from the market altogether.

Opana ER was approved in 2006. Endo introduced a new formulation of the drug, designed to deter abuse, in 2012.

Endo explained the situation in a press release on its website, noting the FDA convened the advisory committees to discuss preand post-marketing data about the abuse of Opana ER, the product’s overall risk-benefit profile, as well as the abuse of oxymorphone products. “Endo remains confident that the body of evidence established through clinical research demonstrates that Opana ER has a favorable riskbenefit profile when used as intended in appropriate patients,” said Matthew W. Davis, senior vice president of research and development for branded pharma-

ceuticals at Endo. “Our top priorities include patient safety and ensuring that patients with chronic pain have access to safe and effective therapeutic options. We plan to work collaboratively with the FDA as the agency completes its evaluation of Opana ER, while advocating to preserve the important benefits of the medicine for patients.”

Endo joins national pharmaceutical distributor AmerisourceBergen as Chester County companies to come under scrutiny as the nation responds to its opioid addiction epidemic. More than 33,000 people died of an opioid overdose in the U.S. in 2015, the most for any year on record, the Centers for Disease and Control Prevention reported. Nearly half of all opioid overdose deaths involve a prescription opioid, the center said.

AmerisourceBergen,

based in the Chesterbrook development in Tredyffrin, agreed in January to pay the state of West Virginia $16 million to settle a lawsuit that alleged the company helped fuel the prescription drug problem statewide. The company denied any wrongdoing. The two other major U.S. pharmaceutical distributors were also sued.

Now, AmerisourceBergen is facing lawsuits from individual counties and cities in West Virginia, which has been particularly hard hit by the epidemic.

On Tuesday, the Charleston Gazette-Mail reported AmerisourceBergen hired a Charleston lawyer to represent it in a lawsuit filed by McDowell County.

In a complaint filed in late December, McDowell County commissioners allege that AmerisourceBergen and other drug distributors essentially laid waste to the county by shipping an excessive number of pain pills there. The commission claims the drug wholesalers failed to guard against the

diversion of prescription opioids, the Gazette-Mail reported.

According to an examination of DEA records by the newspaper, AmerisourceBergen between 2007 and 2012 shipped 1.46 million hydrocodone pills and 193,000 oxycodone tablets to pharmacies in McDowell County.

Reached for comment Wednesday, Lauren Moyer, director of external communications, released a company statement on the West Virginia litigation.

“Distributors such as AmerisourceBergen are responsible for getting Food and Drug Administration approved drugs from pharmaceutical companies who manufacturer them to Drug Enforcement Administration registered pharmacies who dispense them based on prescriptions written by licensed doctors and health care providers,” the statement said. “We provide daily reports of the quantity, type and receiving pharmacy of every single order of controlled

substances we distribute to regulatory and enforcement professionals and there is no evidence that any pain medicines we’ve distributed in West Virginia have been inappropriately diverted before reaching the licensed pharmacies who are our customers.

“Legal filings in West Virginia that attempt to find scapegoats are not based on the root causes of this issue and divert attention and resources from the collective action that’s needed from physicians, wholesalers, pharmacists, patients, insurers, regulators and enforcement authorities to address the impact of prescription drug abuse in our communities,” the statement continued. “We intend to vigorously defend ourselves in this litigation while continuing to work collaboratively to combat drug diversion.”

To contact Business Editor Brian McCullough, call 610-235-2655 or send an email to bmccullough@ dailylocal.com.

PETE BANNNAN – DIGITAL FIRST MEDIA FILE PHOTO Endo Pharmaceuticals near Malvern. The company could have its opioid pain reliever, Opana ER, taken off the market.