House committee issues subpoenas in Ketek investigation
WASHINGTON Days after announcing that it was beginning to investigate current and former investigators for the Food and Drug Administration over the possibility of approving the antibiotic Ketek, even though they knew of possible health concerns, the House Energy and Commerce Committee has voted on issuing subpoenas to FDA officials and for agency documents.
The individuals subpoenaed are current FDA criminal investigators Robert West and Douglas Loveland, former investigator Robert Ekey and clinical research associate Ann Marie Cisneros, who testified before the subcommittee in February 2007 that the manufacturer, Sanofi-Aventis was aware of fraud committed in the Ketek clinical trial known as Study 3014.
The clinical investigator in that trial, Anne Kirkman-Campbell, was sentenced to 57 months in prison for fraud associated with the study. Kirkman-Campbell enrolled patients in the study on days when the office was closed, enrolled her entire staff in the study and blatantly forged consent documents, according to Cisneros.
The documents to be subpoenaed include, but are not limited to, all communications among senior staff at the FDA, the agency’s Office of Legislative Affairs, the Health and Human Services Office of Legislative Affairs and Budget and the HHS Office of the General Counsel, “including communications from the FDA Office of Chief Counsel to Commissioner von Eschenbach and his senior staff.”
Aetna sues Express Scripts over specialty pharmacy
PHILADELPHIA Last month, in the U.S. District Court in Philadelphia, Aetna filed a lawsuit accusing Express Scripts of “knowing, malicious, willful, deliberate and bad faith misrepresentations and outrageous misconduct” in allegedly interfering with pacts between Aetna and Priority Healthcare in the specialty pharmacy market, according to the Associated Press.
Express Scripts acquired Priority Healthcare in 2005, the year after Aetna and Priority had joined together to start a specialty pharmacy venture, Aetna Specialty Pharmacy. After Express Scripts acquired Priority, Aetna exercised its option to buy out Priority’s stake in the joint venture for $75 million, making Aetna Specialty Pharmacy a subsidiary of the health insurer.
Now, Aetna is looking to recover that $75 million plus punitive damages and injunctive relief to make Express Scripts honor the original agreement between Priority and Aetna.
Aetna alleges that Express Scripts, by violating the law and the agreements for the Aetna-Priority joint venture, has “gained an unfair competitive advantage” that precludes the health insurer and its specialty pharmacy business from “prospective advantageous relationships and markets.” Among its claims, Aetna says that its special pharmacy business has been wrongly denied access to certain limited-availability drugs, which has limited its opportunities to develop new markets.
Aetna also alleges that even before the pharmacy benefits manager announced its acquisition of Priority Healthcare in 2005, Express Scripts aimed to injure or destroy Aetna’s efforts to establish a “best of class,” standalone, independent specialty pharmaceutical business by depriving it of best-pricing guarantees in Aetna’s joint-venture agreements with Priority and the benefit of Priority’s supplier and vendor contracts.
Express Scripts has not yet filed a response.
New Mexico disallows second-party prescription pickups without I.D.
GALLUP, N.M. On Jan. 1, a law originated by the New Mexico state pharmacy board was put into effect that required anyone who picked up a prescription for someone else had to present a government issued photo identification, such as a driver’s license or an ID card, according to published reports. The law was created to stop fraudulent prescriptions from being filled.
One of the first people to be arrested under this new law was Michelle Florene Roan, who had attempted this stunt many times and had previously gotten away with it. She was arrested at a Wal-Mart pharmacy after coming in with a fake prescription for a narcotic.
Tom Ortega, a pharmacist at Trust Pharmacy is on the state pharmacy board that enacted this law. “We are a small pharmacy here in Grants, I know everyone who comes in,” Ortega said.
“If I don’t know them, or if they have a prescription from an out-of-state doctor, I contact the doctor’s office to see if it is good,” he said. The reason Roan probably selected Wal-Mart to try to get the drugs is it is located right next to Interstate 40 and is accessible to all the traffic and is very busy, Ortega said.
The new law is working so far; people trying to pick up prescriptions for other people has dropped by 70 percent.