The federal government announced Friday that all drug and medical device makers must publicly disclose payments made to physicians and hospitals in the United States.
All drug companies and medical device makers must publicly disclose what they are paying individual physicians in the United States, the federal government announced Friday.
The information will be made public starting Sept. 2014. This comes after a number of lawsuits resulting in billions made in settlements regarding payments made to doctors. Several large drugmakers have already put the data on their websites, which you can access through the ProPublica Dollars for Docs feature. Two of the companies who have already released their data are Johnson & Johnson and Pfizer.
ProPublic is updating the Dollars for Docs database and will expand the data to 15 companies through late 2012.
The data set for release in September 2014 includes payments made from August to December of 2012. Drug companies must hand over the information to the government by March 2014 and will have 45 days to review the data for accuracy before it is publicly released.
The figures were supposed to be released in 2013 as part of 2010's health care reform law. The Obama administration has given no explanation for the delay. Brian Cook from the Centers for Medicare and Medicaid Services is "working to release the regulations as soon as possible," he said in an email.
Sen. Charles Grassley, R-Iowa, wrote the White House on Tuesday asking officials to provide a release date for the regulation.
"Letting the sun shine in and making information public is basic to accountability," Grassley said in the letter to White House Chief of Staff Jacob Lew. "The sooner we can properly implement this law, the sooner we can establish greater accountability for patients and consumers, especially with medical research."
Physicians on FDA advisory panels have had to inform the agency about conflicts of interest for years. The FDA determines when a waiver due to financial conflict is necessary and keeps monetary arrangements between physicians and drug companies under wraps — even from other members of the panel.
"The question is whether there's some residual fondness for the company because they did pay you," said Sidney Wolfe, director of the health policy research group at Public Citizen. "More disclosure is better."
Disclosure of payments made may bring more scrutiny on doctors serving on FDA advisory boards which help the administration decide on the approval of a new drug.
The Project on Government Oversight has urged the FDA to disclose data since 2010. A year ago the group wrote the FDA again after four advisory panel members backed Yaz, a birth control pill made by Bayer AG. Despite the concern that Yaz and other birth control pills in its class come with a higher risk of blood clotting, the drug was approved. It was discovered the four advisors had worked for Leverkusen, the Germany-based Bayer company that makes generic versions of Yaz.
Ned Feder, staff scientists with the Project on Government Oversight, believes it is difficult to locate skilled advisory member while avoiding conflicts entirely.
"In areas of medicine that are popular these days, I think it's hard to find enough skilled reviewers without possible conflicts of interest and this means that a good committee may have a few such members with possible conflicts," he said.
"The solution, I think, is not to insist on limiting committees to members without conflicts," Feder said. "Simply disclose the financial arrangements of all committee members."
Director of medical programs for the Pew Health Group, Allan Coukell, agrees.
"No drug can be developed or tested without the participation of physicians who enroll patients in clinical trials," he said. "That's an essential part of drug development and we need it to continue."
When the new regulation is active in 2014, there will be penalties for drugmakers who don't properly report their data. These fines range from $1,000 to $10,000 per violation. If a drug company is found to have deliberately failed to report a payment, the fine could be as much as $1 million.