A Medical Device Daily
The U.S. Supreme Court issued its ruling yesterday in the case of Wyeth v. Levine, which tested federal pre-emption of state liability law for makers of drugs, by a vote of 6-3, clearing out any possibility that state laws would be trumped by FDA-mandated labeling when a drug is used in ways not recommended by the drugmaker. The case is seen as part of a larger reversal of the policies of the Bush administration, under which FDA backed pre-emption for drugs.
The case is seen as somewhat different from Riegal v. Medtronic, which the Court decided last year in favor of the defendant, Medtronic (Minneapolis). Part of the reason for the differences in outcomes is that liability pre-emption is encoded in law for PMA devices whereas drug liability is not a statutorily-backed position.
The Medical Device Safety Act of 2008 was introduced into the House of Representatives last year by Rep. Frank Pallone (D-New Jersey) to deal with device pre-emption, but was not passed by the House (Medical Device Daily, June 30, 2008). However, similar bills are said to be in development in both the House and Senate, although Congress will apparently be relieved of any need to craft legislation explicitly disallowing federal pre-emption for drugs.
The Levine case turned on the use of Phenergan, an anti-nausea drug, in Diane Levine of Vermont. Levine's physician introduced two doses of the drug into Levine in a single day, against the labeled recommendation, to counter nausea caused by migraine headaches. The physician who attended to Levine administered the second dose via intravenous push, which the label discourages but does not forbid.
In a statement, Sen. Pat Leahy (D-Vermont), chairman of the Senate Judiciary Committee, said the decision "soundly rejects the anti-consumer position of the Bush administration and reaffirms Congress' primacy concerning the extraordinary power to pre-empt state law." He also states that the decision "reclaims for all American citizens the ability to seek justice in their courts of law."
Stephen Ubl, president/CEO of the Advanced Medical Technology Association (Washington), said in a statement that the Levine decision "does not impact medical devices approved" via the PMA process. He also said that the Medical Device Amendments of 1976 "recognized that complex medical devices warranted federal regulatory oversight that differed from federal regulation of pharmaceuticals." The law, he said, provides "a uniform framework for the regulation of the medical device industry" and that the Levine decision "acknowledges this important distinction."
EMEA publishes stent guidance
The publication last year of a coronary stent guidance by FDA regarding development of drug-eluting stents does not apply to bioresorbable stents, but that is not the case with a guidance published recently by the European Medicines Agency (EmeA; Brussels, Belgium) that deals with clinical development of coronary artery stents.
This guidance covers the entire range, including bare-metal (BMS) and drug-eluting stents (DES), as well as "innovative stents," a group said to include biodegradable stents and stents "incorporating completely new design concepts."
According to the guidance, a clinical trial for a bare-metal stent should run at least six months, whereas trials for drug-eluting and innovative stents should run a year. Follow-up studies should run "for a minimum of three years," and post-market studies may have to include registries that are open to all comers, including patients who have opted for stents outside labeled indications.
The guidance also notes that the resulting data "should be used to feed back directly into device labeling."
Clinical success for the device should be defined in a study as leaving no more than 50% residual stenosis in the affected artery, which can be ascertained by quantitative coronary angiography or by "visual estimation" if the first technique is not possible. The recommended clinical measures include cardiac and non-cardiac death and thrombosis.
CMS announces apnea coverage
The Centers for Medicare & Medicaid Services announced Tuesday its reimbursement policy for testing to diagnose obstructive sleep apnea (OSA), and has opted to cover type II and III testing devices inside or outside of a sleep testing facility, meaning the test can take place in the comfort of one's own bed. CMS proposed such coverage in its announcement at the beginning of the year (Medical Device Daily, Jan. 7, 2009), and its review of comments and literature helped it quickly arrive at a decision.
Acting CMS Administrator Charlene Frizzera pointed out in the March 3 statement that anyone with OSA "face[s] significant risks for cardiovascular disease and other ailments," adding that the decision "establishes nationally consistent coverage and assures that beneficiaries who have sleep apnea can be appropriately diagnosed and referred for treatment."
The decision covers in-home tests for airflow, pulse oximetry and actigraphy, which is a measure of body movement during sleep. However, polysomnography, the modality requiring the attachment of enough leads to the patient's scalp and body to render a visage not unlike something from a Clive Barker movie, must still be conducted in a sleep lab.
FDA tobacco bill in House
Former FDA commissioner David Kessler, MD, seemed to make the case for FDA regulation of tobacco in congressional testimony from 1994, but his FDA may not have had the resource crunch the agency now struggles with. However, a new bill has hit the House of Representatives that would force the agency to regulate tobacco.
The Family Smoking Prevention and Tobacco Control Act of 2009 spans more than 200 pages and would ban tobacco advertising within 1,000 feet of schools and playgrounds and restrict tobacco vending machines to adult-only places of business.
The bill would not permit FDA to ban tobacco, but would give the agency the authority to require tobacco companies to eliminate added ingredients from tobacco products.