Medical Device Daily Washington Editor
Sens. Chuck Grassley (R-Iowa) and Herb Kohl (D-Wisconsin) have reintroduced the Physician Payment Sunshine Act for the 111th Congress, which would require drug and device makers to report payments and gifts to physicians that exceed $100 per year to the Department of Health and Human Services. The law as currently written is billed as including a federal pre-emption of state reporting requirements, but a staffer with the Senate Special Committee on Aging told Medical Device Daily that the bill would pre-empt reporting requirements only for states that have the same or lower level of requirements, not for states that impose a higher standard.
The new iteration of the bill would also trim the frequency of reports required of drug and device makers from the level required in last year's version, from quarterly to annually. The penalties for failure to file those reports, however, could hit $1 million.
According to a statement posted at the web site for the Senate Special Committee on Aging, committee chairman Herb Kohl (D-Wisconsin) said there is "a groundswell of support from every corner" for the bill, and Kohl stated that he is "confident this legislation will pass during the 111th Congress." The statement also quoted the committee's ranking GOP member, Chuck Grassley (R-Iowa), as saying that transparency "fosters accountability, and the public has a right to know about financial relationships."
Kohl's optimism regarding the bill's prospects is shared by Aging committee staff. Ashley Glacel, the committee's press secretary, said in an article by Congressional Quarterly that the bill "has been out there for a year and half, and ... it has been fine-tuned." She described it as "a really smart and strong piece of legislation."
Glacel was unable to tell MDD which provisions of the bill might spark the most debate in the committee, let alone on the Senate floor. "The version of this from the last Congress was vetted in three hearings," she said, adding that feedback from the states drove the language of the pre-emption provision. She also said that representatives of several states indicated concern "that their stronger laws would be made moot, so we've inserted a very narrow pre-emption clause" that allows states to promulgate tougher laws.
Stephen Ubl, president/CEO of the Advanced Medical Technology Association (AdvaMed; Washington), said in a statement that the association commends the senators "for their continued leadership on this important issue," but he acknowledged that AdvaMed is still looking the bill over. Ubl reiterated the association's belief that "any federal disclosure legislation [should] create a uniform national standard to prevent a patchwork approach by all 50 states." AdvaMed did not respond to a request for further comment.
Mark Leahy, president of the Medical Device Manufacturers Association (Washington), also did not respond.
FDA okays first embryonic stem-cell trial
FDA recently gave the nod to a first-in-man embryonic stem cell trial that will be the first trial of any kind for such cells. The company that achieved this milestone is Geron (Menlo Park, California), a biotechnology company that will evaluate the use of embryonic stem cells for spinal cord injuries in as many as 10 patients.
Geron's president/CEO, Thomas Okarma, said in a statement that the approval "is the dawn of a new era in medical therapeutics," offering therapeutic options "beyond what pills and scalpels can ever do."
The recently-departed Bush Administration imposed a moratorium on the addition of embryonic stem cell lines that could be funded by federal research dollars, but some in industry have also complained that FDA has not been clear on its expectations for stem cell trials, which has impeded privately funded development of embryonic stem cell research. President Obama made the issue part of his campaign platform, but has recently said he would defer to the legislature on the issue, stating that he "like(s) the idea of the American people's representatives expressing their views on an issue like this."
Geron's study proposal will address a one-year therapy regime for spinal-cord injuries to commence within two weeks of the injury. Geron will apply to FDA at one year to increase dose levels and expand the study population. According to wire service reports, FDA needed almost a year to scrutinize Geron's application, which is said to have covered 21,000 pages.
FDA reprint guidance draws fire
FDA's latest guidance for the distribution of medical journal reprints discussing off-label uses for drugs and devices was bound to ruffle feathers on Capitol Hill, but makers of drugs and devices see the guidance as an appropriate move.
The January guidance states that "public health may be advanced by healthcare professionals' receipt of medical journal articles and medical or scientific reference publications on unapproved new uses" of drugs and devices, but the agency stuck with the proviso that visiting sales personnel deliver such materials to doctors during visits when no sales discussions take place.
Despite the proviso segregating sales talks and literature visits, Rep. Henry Waxman (D-California), the new chairman of the House Energy and Commerce Committee, described the guidance as "a long-coveted parting gift" on the part of the Bush administration, according to wire service reports. Waxman also expressed the hope that the policy "will be carefully re-examined" by the Obama administration's appointee for FDA commissioner.
FDA to hold workshop
FDA reported last week that it will hold a public workshop that will address unique medical device identification standards next month. The agency's statement notes that the event will take place Feb. 12 at the Gaithersburg Marriott Washingtonian Center in Gaithersburg, Maryland, just outside the nation's capital. The announcement also notes that the meeting will be webcast, although details on the webcast were not included in the announcement.