Last 7 Days of Daily Updates

Tuesday, November 18, 2008

Brand-name drug makers can be held liable for certain injuries caused by their generic competitors, a California court said this month. Although the California court sidestepped direct issues of FDA preemption, its decision is relevant to that debate, sources say.

Monday, November 17, 2008

Senate Finance Committee Chair Max Baucus (D-MT) said he plans to meet Tuesday morning with Senate health committee Chair Ted Kennedy (D-MA) and the top GOP members of both committees to hash out jurisdictional issues related to health care reform. Baucus indicated he still hopes to move health reform legislation in a bipartisan manner, but is willing to resort to partisanship if necessary.

House Democrats are investigating allegations that scientists in FDA's device center were intimated and harassed into approving unsafe products. Several scientists sent a letter to Energy and Commerce Committee Democrats alleging a pattern of interference and retribution among senior center officials.

Drug makers believe the development of safety biomarkers will be stalled until FDA changes guidelines on data submissions from studies on biomarkers, sources say. FDA gave verbal assurance several weeks ago it has changed its policy, but FDA’s Web site still doesn’t reflect that, an industry source says.

President-elect Barack Obama said during the campaign that he intended to roll back the Bush administration’s push for FDA preemption, a doctrine the agency has advanced through both court briefs and regulations. Now, stakeholders are questioning whether preemption will be a high priority for Obama and the Democratic Congress, as well as the mechanics of a policy reversal.

Hundreds of companies that develop biologic drugs are not bound by the marketing restrictions instituted this summer by the Pharmaceutical Research and Manufacturers of America, prompting fears within the industry that those companies are enjoying an unfair competitive edge. The Biotechnology Industry Organization decided against adopting the PhRMA code at a board meeting this fall, according to notes from that meeting obtained by FDA Week.

Friday, November 14, 2008

The congressionally mandated Medicare Payment Advisory Commission seems poised to recommend a new payment system for hospice care that would reduce reimbursement as lengths of stays increase and require CMS to provide greater oversight of hospice certifications and recertifications.

Industry lawyers say if Rep. Henry Waxman (D-CA) prevails in his bid to take over the House Energy and Commerce Committee, it could result in more FDA oversight of diagnostic tests developed in laboratories, which include genetic tests. The American Clinical Laboratory Association opposes more FDA oversight of such tests.

A prominent industry consulting firm has floated a white paper calling for the incoming Obama administration to restructure the national occupational health and safety debate by fixing what it calls a broken OSHA standard-setting process. ORC Worldwide prescribes a “culture change” at OSHA that it says would require a structured national dialogue facilitated by the new administration to prioritize key long-term safety and health goals, and for employers to adopt a systems-based rather than hazard-by-hazard approach to reducing occupational safety risks.

Reps. Henry Waxman (D-CA) and John Dingell (D-MI) remain locked in a battle for control of the House Energy and Commerce Committee, which has broad authority over health care. Energy and Commerce health subcommittee Chair Frank Pallone has gotten behind Waxman, and Dingell picked up support this week from members of the Congressional Black Caucus.

FDA tried unsuccessfully for weeks to get Lotte U.S.A. to recall cookies contaminated with melamine, consumer advocates say. Yet FDA kept quiet about the company’s reluctance, which consumer advocates say is a perfect example of why the agency needs mandatory recall authority.

Thursday, November 13, 2008

House Energy and Commerce leaders said Thursday they want to include a hike to the federal Medicaid matching rate in a second stimulus package, but signaled Democrats haven’t decided whether to push a scaled-back bill next week that potentially could gain President Bush’s support or simply wait to pass a more robust stimulus bill next year that would likely be signed by President-elect Barack Obama.

The American Clinical Laboratory Association is concerned that growing attention to a subset of genetic tests might spur legislation or FDA regulations that could stifle overall genetic test development. In response, ACLA has launched an informational campaign about the tests.

Imaging industry associations are divided on CMS’ decision to renege in its final physician fee schedule rule on its earlier proposed expansion of independent diagnostic testing facility (IDTF) provisions that would have required physician practices that offer the services to register as IDTFs.

The inclusion of four new imaging efficiency measures in CMS’ hospital Outpatient Prospective Payment System (OPPS) final rule disappoints leading hospital groups, which in the days after the agency published the rule called the measures not ready for prime-time.

FDA on Wednesday issued an import alert blocking shipments of all bulk milk and milk ingredients from China as well as all finished products containing Chinese milk ingredients, including animal feed. By issuing such a broad import alert, FDA has acted more aggressively than many other developed countries in addressing the Chinese melamine scare. The agency has been under pressure from Congress and consumers to more stridently police Chinese imports since the public learned in September that tainted infant formula sickened thousands of Chinese babies, killing some.

Wednesday, November 12, 2008

Senate Finance Chair Max Baucus (D-MT) on Nov. 12 unveiled a health reform plan a year in the making that calls for universal health coverage achieved through employer mandates and tax credits, reforms to public Medicare and private insurance, and expanded coverage under Medicare, Medicaid and SCHIP. He also proposes a national Health Insurance Exchange entity, with a public plan option. Baucus goes beyond President-elect Barack Obama’s call for all children to be provided health insurance, advocating an individual mandate.

A coalition of more than 75 health advocacy groups sent a letter on Wednesday (Nov. 12) to congressional leaders seeking support for legislation that would strip away the two-year waiting period that beneficiaries eligible for Social Security Disability Insurance (SSDI) must endure to get Medicare coverage. Senate Finance Chair Max Baucus (D-MT) announced later in the day that he included the wait period deletion in his comprehensive health care reform proposal.

Personalized medicine advocates hope that FDA will offer incentives for genomics research under an Obama administration, particularly research to safety biomarkers. Obama has been a supporter of such incentives, sources say.

CMS is not cutting any slack to a Devine, TX, entrepreneur who is trying to break into the e-prescribing market via her networking Web site, called Weno Healthcare. The entrepreneur, frustrated by her inability to navigate CMS’ Part D rules, appealed to the Small Business Administration, and CMS recently told the SBA ombudsman that Weno Healthcare must meet the same e-prescribing standards followed by other vendors and offered advice on how that could be done.

FDA appears to be stepping up its scrutiny of how drug companies handle post-market adverse event reports and how they ensure that contract research organizations comply with clinical research standards, an industry lawyer says.

Hundreds of companies that develop biologic drugs are not bound by the marketing restrictions instituted this summer by the Pharmaceutical Research and Manufacturers of America, prompting fears within the industry that those companies are enjoying an unfair competitive edge. The Biotechnology Industry Organization decided against adopting the PhRMA code at a board meeting this fall, according to notes from that meeting obtained by FDA Week.