Congress

House Democrats are preparing legislation that may work as an incentive for beneficiaries to couple traditional Medicare with a supplemental benefit such as Medigap, a supporter of Medicare Advantage (MA) payment cuts says. At a May 3 Ways & Means Committee hearing, lawmakers also pushed various proposals to eliminate the Part D late-enrollment penalty, modify the low-income subsidy (LIS) asset test and streamline applications for state-federal health programs.

Consumer advocates are unhappy with changes to consumer drug advertising restrictions negotiated in an amendment to the FDA bill the Senate is debating on the floor. The amendment scraps earlier language that would have let FDA impose 2-year moratoriums on drug ads and in exchange lets FDA require safety information as part of consumer ads -- but consumer advocates say the new requirement may be hard to implement.

BOSTON--Former FDA head Mark McClellan praised biogenerics legislation proposed by several House Oversight and Government Reform Committee members that is seen as largely favorable to the innovator biopharmaceutical industry. Two retired healthcare lawmakers -- former Ways & Means Chair Bill Thomas (R-CA) and former Louisiana senator John Breaux -- agreed the bill lends to a positive discussion about creating an FDA approval pathway for follow-on-biologics.

A bipartisan team of Congress members, backed by a highly diverse and influential group of stakeholders, introduced a wide-ranging SCHIP reauthorization bill on Thursday that relies on public and private initiatives to expand and streamline the program. The Healthy Kids Act, authored by House Ways & Means Committee members Rahm Emanuel (D-IL) and Jim Ramstad (R-MN), and co-sponsored by several well-placed colleagues, would appropriate $60 billion over five years to the popular State Children's Health Insurance Program (SCHIP).

Democratic Sen. Hillary Clinton (NY) said Friday (May 4) Congress should let FDA charge user fees to inspect food processors and storage facilities. Such fees are not included in a food safety amendment attached Wednesday to the Senate FDA reform bill, and would be opposed by a key House food safety advocate.

Former FDA commissioners told House lawmakers Tuesday (May 1) FDA should renegotiate treaties with other countries, particularly China, to ensure their food inspection standards are up to par with U.S. requirements and also improve domestic food safety oversight. Current food agreements are inadequate in light of recent reports of human and pet food contamination, two of the former commissioners said.

Senators Wednesday (May 2) voted unanimously to attach to the FDA reform bill a compromise food safety measure that would require food and pet-food processors to report suspected contamination to FDA, give agency inspectors easier access to company records during inspections, and make FDA write processing and ingredient standards for pet food. The compromise does not let FDA mandate food recalls, sidestepping an earlier push by key Democrats to give the agency such authority.

The Senate will pick up debate on the FDA reform bill Thursday morning with a drug importation amendment, which if passed could draw a presidential veto to the entire bill (see related story).

On Wednesday lawmakers added food safety legislation to the omnibus FDA bill and promised to work a biogenerics measure for inclusion during conference (see related stories). Senators are still trying to compromise on a drug consumer advertising measure in the bill, which lawmakers say is the main hold up.

The White House signaled to lawmakers Monday (April 30) the president would veto the FDA reform/user feel bill if drug reimportation language is added, and would strongly oppose the addition of follow-on biologics to the FDA bill being debated on the Senate floor. The administration also urged lawmakers to scrap the bill's drug advertising restrictions and raised continued concerns with its risk management requirements.