Tag Archives: pharma legal news

Trump administration plans to require drug companies to include prices in ads

BY JESSIE HELLMANN AND NATHANIEL WEIXEL – 

Drug companies would be required to list prices in advertisements under a Trump administration proposal released Monday.

Under the new proposal, which was announced by Health and Human Services Secretary Alex Azar, drug manufacturers would need to state the list price of a 30-day supply of any drug that is covered through Medicare and Medicaid and costs at least $35 a month.

The plan is the boldest step the administration has taken to date as part of its efforts to bring down drug prices, and puts the administration squarely at odds with the powerful prescription drug lobby.

“Patients deserve to know what a given drug will cost when they’re being told about the benefits and risks it may have,” Azar said during a speech Monday in Washington, D.C.

“And they deserve to know when a drug company has pushed its prices to abusive levels, and they deserve to know this every time they see a drug advertised to them on TV.”

The proposal will be officially published Wednesday, and will be open for public comment for 60 days.

According to HHS, the 10 most commonly advertised drugs have list prices ranging from $535 to $11,000 per month for a usual course of therapy. Under the proposal, companies would be required to post that information in clear, legible text onscreen at the end of the ad.

HHS officials said the agency will publish a list of companies that don’t comply with the policy. Those companies would also be subject to potential litigation, officials said during a press call.

The pharmaceutical industry opposes the proposal, arguing it would confuse consumers because a drug’s list price is often lower than what the patient will actually pay.

PhRMA, the deep-pocketed trade group representing pharmaceutical companies in the U.S., tried getting ahead of Azar’s announcement, telling reporters Monday morning that its members would begin directing patients to more information about drug costs in television ads.

Every ad mentioning a prescription drug by name will include a voiceover or text telling patients to go to a company-sponsored website where they can find information about the list price, as well as a range of potential out-of-pocket costs and potential patient assistance. 

“We want patients to have more cost information and support using direct-to-consumer advertising,” said PhRMA President Steven Ubl, but “just including list prices is not sufficient and would be misleading.”

Azar acknowledged PhRMA’s plan in his speech Monday afternoon, but said it doesn’t go far enough. 

Full Read – https://thehill.com/policy/healthcare/411505-trump-administration-to-require-drug-companies-include-prices-in-ads

6 pharma executives face criminal charges for alleged fentanyl racketeering scheme

Six pharmaceutical executives who worked for Chandler, Ariz.-based Insys Therapeutics were arrested Thursday on charges that they led a nationwide conspiracy to bribe clinicians to unnecessarily prescribe fentanyl-based pain medication, according to the Department of Justice.

The government claims the executives conspired to bribe physicians and medical practitioners in several states, many of whom worked in pain clinics, to prescribe their pain medication called Subsys. This narcotic contains fentanyl, a highly addictive synthetic opioid, and is intended to treat cancer patients suffering intense episodes of breakthrough pain.

In exchange for kickbacks and bribes, practitioners allegedly wrote large numbers of prescriptions for patients, few of whom were diagnosed with cancer. The indictment also alleges the former Insys executives conspired to defraud health insurers that showed reluctance to approve payment for Subsys when it was prescribed to non-cancer patients. The defendants allegedly did so by establishing a “reimbursement unit” that obtained prior authorization directly from insurers and pharmacy benefit managers.

Here are the names of the defendants, all of whom are no longer employed by Insys Therapeutics, along with the respective charges they face:

  • Michael Babich, former president and CEO: conspiracy to commit racketeering, conspiracy to commit wire and mail fraud and conspiracy to violate the Anti-Kickback Law
  • Alec Burlakoff, former vice president of sales: Racketeer Influence and Corrupt Organizations Act conspiracy, mail fraud conspiracy and conspiracy to violate the Anti-Kickback Law
  • Richard M. Simon, former national director of sales: RICO conspiracy, mail fraud conspiracy and conspiracy to violate the Anti-Kickback Law
  • Sunrise Lee, former regional sales director: RICO conspiracy, mail fraud conspiracy and conspiracy to violate the Anti-Kickback Law
  • Joseph A. Rowan, former regional sales director: RICO conspiracy, mail fraud conspiracy and conspiracy to violate the Anti-Kickback Law
  • Michael J. Gurry, former vice president of managed markets: RICO conspiracy and wire fraud conspiracy

Criminal charges are rarely pressed in cases involving pharmaceutical companies, and several agents noted the severity of the charges in statements.

Full Read – http://www.beckershospitalreview.com/legal-regulatory-issues/6-pharma-executives-face-criminal-charges-for-alleged-fentanyl-racketeering-scheme.html

Drug industry hired dozens of officials from the DEA as the agency tried to curb opioid abuse

By Scott Higham, Lenny Bernstein, Steven Rich and Alice Crites

Pharmaceutical companies that manufacture or distribute highly addictive pain pills have hired dozens of officials from the top levels of the Drug Enforcement Administration during the past decade, according to a Washington Post investigation.

The hires came after the DEA launched an aggressive campaign to curb a rising opioid epidemic that has resulted in thousands of overdose deaths each year. In 2005, the DEA began to crack down on companies that were distributing inordinate numbers of pills such as oxycodone to pain-management clinics and pharmacies around the country.

Since then, the pharmaceutical companies and law firms that represent them have hired at least 42 officials from the DEA — 31 of them directly from the division responsible for regulating the industry, according to work histories compiled by The Post and interviews with current and former agency officials.

The number of hires has prompted some current and former government officials to ask whether the companies raided the division to hire away DEA officials who were architects of the agency’s enforcement campaign or were most responsible for enforcing the laws the firms were accused of violating.

“The number of employees recruited from that division points to a deliberate strategy by the pharmaceutical industry to hire people who are the biggest headaches for them,” said John Carnevale, former director of planning for the White House’s Office of National Drug Control Policy, who now runs a consulting firm. “These people understand how DEA operates, the culture around diversion and DEA’s goals, and they can advise their clients how to stay within the guidelines.”

Read Full – https://www.washingtonpost.com/investigations/key-officials-switch-sides-from-dea-to-pharmaceutical-industry/2016/12/22/55d2e938-c07b-11e6-b527-949c5893595e_story.html?utm_term=.a6e6664d1a03