Newsroom RX

• Wall Street Journal: China Never Investigated Tainted Heparin, Says Probe 07/21/2010
• Wall Street Journal: J&J starts disclosing payments to doctors 07/09/2010

  Johnson & Johnson is the latest drug company to disclose payments made to doctors, reports the Wall Street Journal (subscription required).

  Pew Prescription Project Director Allan Coukell applauded the voluntary disclosure, but said that the information is hard to synthesize because it is spread out on different websites of the company's pharmaceutical units.

  "It's not all in one place," Coukell told the Journal. "We would have rather seen the multiple J&J sites consolidated into one. That said, I give them credit for doing what they've done. We applaud any company that takes voluntary steps towards this kind of disclosure."

  The company did not make aggregate data available, but Obsidian, a company that aggregates physician payment data, calculated that J&J's Ortho-McNeil-Janssen division paid doctors $1.76 million in the first three months of 2010.

  Under a provision in the Affordable Care Act, drug and device companies will be required to disclose payments made to physicians and teaching hospitals, and those payments will be posted to a national public website beginning in 2013. (More on the Sunshine Act here.)

  Read the Postscript blog for more on companies that are disclosing physician payments and the importance of the data's format and uniformity.

   

   

• Pharmacy fraud in Baltimore highlights need for better prescription drug-tracking system 07/07/2010

  A Baltimore pharmacist has been sentenced to 57 months in prison for making fraudulent claims and misbranding hundreds of thousands of bottles of drugs from an unlicensed supplier, the FDA Office of Criminal Investigations said last week.  In an inspection during 2008, officials found more than 200,000 bottles of misbranded drugs in Pamela Arrey’s Medicine Shoppe, as well as drugs that had expired, or had altered labels.
   
  According to an FDA press release, “Arrey misbranded and relabeled prescription drugs she had purchased in large drums from an unlicensed supplier, for resale in her pharmacies. Arrey admitted that she filled prescription orders for pharmacy customers with misbranded pharmaceuticals, including Metformin, an oral diabetes medication used to help control blood sugar levels, and Gabapentin, an anti-epileptic medication used to treat seizures.”

  Misbranding and counterfeiting schemes like Arrey’s—which involved diabetes and anti-seizure medications—highlight the need for a federal electronic track-and-trace system, so that drugs can be traced back to their original source and verified at each transaction point, from production to pharmacy shelf. Congresswoman Rosa Delauro (D-CT), who chairs the House subcommittee on FDA appropriations, called for such a system to be developed in committee’s Chairman’s Mark last week, and federal track and trace legislation has been introduced in previous sessions.

  For more on drug safety and the importance of developing a prescription drug tracking system, visit the Pew Prescription Project’s Securing a Safe Drug Supply.

• House Subcommittee sets $2.571B mark for FDA in FY 2011 07/03/2010

  The Chairman’s Mark from the House Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Subcommittee released this week would give the FDA $2.571 Billion for FY 2011, $55 million more than the administration’s budget request for FY2011 and $214 million than this year. 
   
  Subcommittee Chairwoman Rosa DeLauro (D-CT) praised the agency but voiced her continued concerns over drug safety, saying the appropriation would go, in part, toward inspecting foreign drug making facilities.
   
  “We have also included report language ... on the status of developing standards for a track and trace system for prescription drugs, one that would document all parties involved in the prior sale, purchase, and trade of a given prescription drug beginning with the manufacturer,” DeLauro said. “This is critical to improving the security of the drug supply chain from counterfeit or other substandard products and to protecting consumers.”
  
  For more on drug safety, visit the Pew Prescription Project’s Securing a Safe Drug Supply.

• Wall Street Journal: AAMC says teaching hospitals should have COI guidelines 07/01/2010