Tennessee Bill Will Allow Drug Companies To Market Their Products For Off-Label Uses
Pharmaceutical companies traditionally have been restricted from distributing information about off-label uses to doctors, which they say is a violation of free speech. Critics, however, are worried that more freedom for the drugmakers could jeopardize patient safety.
Stat:
Tennessee Becomes The Second State To Allow Off-Label Promotion
As drug makers seek wider latitude to promote their medicines, Tennessee has become the second state in the U.S. to enact a law allowing the companies to market their products for so-called off-label uses — so long as the information given doctors is truthful. The law, which goes into effect on July 1, arrives more than a year after Arizona adopted the first such law in the country. Moreover, it comes amid rising pressure on the Food and Drug Administration to loosen regulations for off-label promotions, which is one of the most contentious issues to roil both the agency and the pharmaceutical industry. (Silverman, 5/10)
In other pharmaceutical news —
Reuters:
DoJ Investigates Mylan On Trade Compliance For Certain Products
Pharmaceuticals company Mylan NV said on Thursday that one of its subsidiary received a civil investigative demand from the U.S. Department of Justice regarding its compliance with the Trades Agreement Act (TAA) for certain products, according to a filing with the U.S. Securities and Exchange Commission. The company also said certain employees of Mylan S.p.A. were served with search warrants issued by the public prosecutor's office in Milan, Italy, seeking information concerning interactions with an Italian hospital and sales of certain reimbursable drugs. (Krothapalli, 5/10)
Los Angeles Times:
L.A. Cracks Down On Unlicensed And Counterfeit Pharmaceuticals
The Los Angeles city attorney filed three lawsuits Wednesday against several individuals accused of selling illegal, banned, misbranded or counterfeit pharmaceuticals. The lawsuits follow an extensive investigation by multiple law enforcement agencies in Los Angeles, Orange County, San Diego and Arizona, officials said. (Etehad, 5/9)
Minnesota Public Radio:
Soaring Insulin Prices Prompt Protest At Capitol
Some health care providers and consumers are using this Mother's Day weekend to raise awareness of the soaring cost of diabetes drugs. There's a rally at the state Capitol Saturday to call attention to the severe consequences and possibly even death facing people who can't afford enough insulin. (Zdechlik, 5/11)
