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Federal prosecutors are investigating whether major drug manufacturers, including
Sanofi
HER,
SNY -1.20%
Gilead Sciences
Inc.
BROWN 1.04%
and
Biogen
Inc.
BIIB 0.73%
According to a Wall Street Journal study on securities deposits, there could be laws violation by providing free services to doctors and patients.
Pharmaceutical companies claim that services, such as nurses and reimbursement assistance, help doctors and patients. But practices, which have become more prevalent as pharmacists introduce more complex and expensive drugs, are looking at their illegal business objective: to drive sales.
Amgen
Inc.
AMGN 0.14%
Bayer
AG
and
Eli Lilly
& Co. faces legal action against whistleblowers alleging that the services are illegal bribes. Meanwhile, the California Insurance Commissioner continued this week
AbbVie
Inc.
ABBV -0.37%
accusing the company of providing bribes in the form of nursing support and insurance assistance to entice doctors to write prescriptions for his medicine against the drug Arthritis, Humira.
Overall, federal investigations, whistleblower lawsuits and the California case suggest that the growing supply of free services by the drug industry is beginning to attract the same kind of attention as the sales practices of corporate dinners and trips.
AbbVie's share price has declined by approximately 3% since the filing of the complaint. North Chicago, Illinois, said that California's allegations, as well as a lawsuit filed by a former informant, were unfounded and that they complied with federal and state laws. He stated that he provides services to patients once they have been prescribed Humira.
Bayer and Lilly said the lawsuits against whistleblowers against them were unfounded, and Amgen declined to comment.
The lawsuit against AbbVie could have broader implications for the industry as the practices it describes "are similar to those that other biopharmaceutical companies have also used to help patients take medications prescribed by their physician. ", Say analysts Credit Suisse.
Drug companies are looking for an ever-wider range of practices that they believe help patients, from coping fees to education to illness. However, prosecutors and critics say that such practices, while useful, aim to encourage the continued use of specific drugs rather than other alternatives. In addition, some critics argue that such tactics can increase the overall costs of health care by pushing more expensive drugs on people.
A federal anti-bribe law prohibits payments to obtain prescriptions for medications or other medical care reimbursed by government health programs.
The Department of Justice has surveyed donations from drug manufacturers to third-party charities that help pay for Medicare patients' drug costs. This practice tends to boost overall sales because Medicare pays the bulk of the costs. Last year,
United Therapeutics
Corp.
has agreed to pay $ 210 million to settle the allegations of the Department of Justice related to the use of a third-party foundation to pay the copays. United Therapeutics did not admit responsibility.
In the case of Sanofi, the US District Attorney's Office for the Southern District of New York sent a request for a civil inquiry to the US unit in August 2017 requesting documents and information about the "educational program". Sanofi ". Government officials sometimes seek broad information through such requests, but this does not always lead to other measures.
The Sanofi program was made up of nurse practitioners and other health professionals who answered patients' questions about diabetes and trained them to use Sanofi's diabetes products, said a spokesperson for Sanofi. Sanofi. The program is no longer in effect.
Sanofi is cooperating in the investigation to find out if it has violated the anti-recoil law, the spokeswoman said. A spokesman for the US Attorney's Office in New York declined to comment.
Gilead Sciences has received inquiries from both the state and the federal government. In September 2017, the US District Attorney's Office in Pennsylvania requested information about Gilead's "Reimbursement Offers, Clinical Training Programs, and Interactions with Specialty Pharmacies" for its anti-cancer drugs. Hepatitis S, Sovaldi and Harvoni. The US Attorney's Office in Pennsylvania declined to comment.
In October 2017, the California Department of Insurance and the Alameda County Attorney's Office in California, sent a summons to Gilead asking for documents on similar issues, said Gilead. The company stated in its filings that it cooperated with both investigations. A spokeswoman for the company declined to comment further.
Biogen, which manufactures several multiple sclerosis medications, received a request from the federal government for a civil investigation in December 2016 for documents and information about its relationship with "entities providing clinical training and reimbursement services". . The company said in the deposits that she was cooperating with the government; a spokesman declined to comment further.
The lawsuit filed in California against AbbVie said the company had sent registered nurses to visit patients to teach them how to inject the Company's hypertension drug, Humira, and provide further assistance. In the trial, AbbVie also provided staff to help doctors' offices fill out the necessary paperwork to get the drug back, which can cost more than $ 50,000 a year.
According to the lawsuit, these services saved doctors time and money, prompting them to prescribe Humira, the world's best-selling drug. In 2017, Humira generated $ 18.4 billion in global sales, including US $ 12.4 billion in the United States. California claims damages on behalf of private insurers who have paid $ 1.29 billion since 2013
State Insurance Commissioner Dave Jones said the nurses deployed by AbbVie had been trained to ensure patients stay on Humira and avoid questions about Humira's risk of side effects.
"There is particular concern that decisions about medical care are motivated by bribes and incentives, as opposed to what is in patients' best interests," Jones said in an interview.
California's lawsuit against AbbVie updates a lawsuit launched by Lazaro Suarez, who worked in 2013 and 2014 as a Humira Nurse Educator for an entrepreneur from AbbVie, Quintiles, now a member of 39; IQVia Holdings. filed a revised complaint on Tuesday.
The free services of pharmaceutical companies to doctors and patients may seem positive, but it "hampers medical decision-making," said Rachel Geman, Suarez's lawyer.
Mr. Suarez also filed a lawsuit against AbbVie in a federal Illinois court with similar allegations. Mr. Suarez could collect some of the money the federal government or California collects through settlements or judgments.
A spokesman for IQVia, who is not charged in the California lawsuit, said the company adhered to the highest ethical standards.
Write to Peter Loftus at [email protected]
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