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Congress

April 23, 2007 | Daily News

Editors' Note: The original online version of this story said Sen. Charles Grassley was part of the deal reached with conferees, based on information Inside CMS received from Sen. Richard Durbin. Durbin later clarified that he had merely suggested to Baucus that Grassley be a part of the negotiation process and had actually never personally met with the Iowa senator or his staff. Grassley aides confirm he was not involved in the compromise, and still objects to the amendment (see related story).

April 20, 2007 | Daily News

Senate Finance Committee members Gordon Smith (R-OR) and Jeff Bingaman (D-NM) last week dropped several pieces of legislation that aim to hike the number of low-income seniors enrolled in Medicare Part D.

April 20, 2007 | Daily News

Senate Aging Committee Ranking Republican Gordon Smith (OR) Wednesday asked the Congressional Research Service to conduct a 50-state survey to help Congress determine what role the federal government, states and industry should play in regulating pharmacy compounding of so-called "bioidentical" hormones. He also called for stronger enforcement by FDA and the Federal Trade Commission of compounders that continue to make health claims and market bioidenticals.

April 20, 2007 | Daily News

The Senate health committee tucked into the FDA reform bill it passed this week a measure subjecting state-legalized medical marijuana to FDA regulations. However, a group supporting medical marijuana says the legislation may not be enforceable.

Sen. Tom Coburn (R-OK) offered the measure as an amendment during mark-up of the FDA reform/drug user fee bill. Many Democrats objected, but enough voted for it to pass.

April 20, 2007 | Daily News

House and Senate leaders will meet Monday (April 23) to hash out differences surrounding their emergency 2007 spending bills -- including approximately $750 million to plug SCHIP deficits this year -- but observers are already looking further ahead, as a promised presidential veto leaves in question how Democrats will move the legislation before states are forced to dip into Medicaid or cut kids' coverage.

April 19, 2007 | Daily News

Several amendments by GOP members to narrow the scope of proposed FDA's authorities failed or were withdrawn during a marathon Senate health committee markup of sweeping FDA reform and user fee legislation Wednesday (April 18). The amendments, or new versions of them, are likely to reemerge during the upcoming Senate floor debate.

April 19, 2007 | Daily News

Senate health committee Chair Edward Kennedy (D-MA) is working to strike a deal on biogenerics legislation before the FDA reform/drug user fee bill is taken up by the full Senate. Kennedy circulated a draft bill late last week but failed to gain support from the committee's top GOP member prior to Wednesday's mark-up of the FDA Revitalization Act (S. 1082).

April 18, 2007 | Daily News

Now that Democrats in both chambers have passed budget plans with language allowing up to $50 billion to reauthorize SCHIP, the next sticking point in the debate seems destined to revolve around who exactly should be covered under the popular program, which will sunset at the end of September without legislative action.

April 18, 2007 | Daily News

Contentious Senate legislation that would have allowed the government to negotiate lower drug prices under Medicare Part D failed on a procedural vote Wednesday morning, garnering only 55 of the 60 votes needed to avert a GOP filibuster threat. Future Senate action on the issue is in doubt, with Senate Majority Leader Harry Reid (D-NV) Tuesday (April 17) blaming Republicans for protecting the pharmaceutical and insurance industries, though key lawmakers have vowed the fight is far from over.

April 18, 2007 | Daily News

The Senate health committee Wednesday (April 18) passed an FDA reform/user fee bill that no longer requires risk evaluation and mitigation strategies (REMS) for all drug applications. The committee-passed bill also gives FDA more authority to force drug label changes than did an earlier draft, requires that drug approval documents be published, requires more clinical trials be registered, changes pediatric exclusivity measures, includes medical device user fees and adds $50 million annually in drug fees to pay for REMS.

April 17, 2007 | Daily News

The future of contentious legislation allowing the government to negotiate lower drug prices under Medicare Part D is in further doubt after Senate Majority Leader Harry Reid (D-NV) indicated Tuesday (April 17) that a motion to force a vote on the bill will probably fail this week.

April 17, 2007 | Daily News

Rep. Anna Eshoo (D-CA) said Tuesday (April 17) biogenerics legislation sponsored by fellow House Energy and Commerce health subcommittee member Rep. Henry Waxman (D-CA) has no place in a prescription drug user fee bill that is slated for mark up in the Senate Wednesday. Eshoo and several other legislators said they wanted to pass a "clean" bill devoid of other drug safety and pediatric device measures.

April 17, 2007 | Daily News

The leading Senate drug safety bill no longer requires risk evaluation and mitigation strategies (REMS) for all drug applications, according to a revision of the bill floated a day before it is to be marked up April 18 by the Senate health committee. The "chairman's mark" of S. 1082 also now requires that drug approval documents be published, requires more clinical trials be registered, changes pediatric exclusivity measures, and includes medical device user fees.

April 17, 2007 | Daily News

The Pharmaceutical Research and Manufacturers of America is circulating among its members a document outlining specific changes the group wants to the Senate drug safety bill slated for markup Wednesday.

April 16, 2007 | Daily News

Leading consumer groups point to FDA's recent failure to prevent misleading television ads for two key drugs as a reason Senate lawmakers should mandate agency preclearance of direct-to-consumer ads. The advocates are hopeful a group of senators will urge Senate health committee Chair Edward Kennedy (D-MA) to add stricter DTC controls among other changes to his newly unveiled omnibus FDA reform/drug user fee bill when it is marked up this week.

April 16, 2007 | Daily News

House Energy & Commerce Democrat Edward Markey (MA) is mulling legislation to scrap a new CMS rule that forces suppliers of durable medical equipment (DME) to bid competitively for Medicare contracts, according to one trade group supportive of such a repeal.

April 13, 2007 | Daily News

Senate Finance Committee Chair Max Baucus (D-MT) indicated this week that reforming the controversial Medicare Advantage (MA) program will be difficult without more regional impact data, and hinted that applying additional transparency and comparative effectiveness measures to MA -- as he is pushing for Part D -- would go a long way toward improving the controversial program.

April 13, 2007 | Daily News

Senate health committee chair Edward Kennedy (D-MA) and top GOP member Mike Enzi (R-WY) are working with a small group of lawmakers on alternative biogenerics legislation that could be attached to the omnibus drug user fee/ FDA reform bill to be marked up April 18, key congressional staffers said Friday (April 13). The bill would give brand biologic drug makers intellectual property rights they have clamored for, said Enzi health staffer David Schmickel.

April 13, 2007 | Daily News

The Senate Finance Committee late Thursday passed 13-8 a bill giving HHS the authority to negotiate drug prices under Medicare Part D, but the panel's top Republican is signaling a possible GOP filibuster when the bill hits the floor next week. Democrats are also gearing up to offer multiple floor amendments, including one that would mandate HHS negotiate prices similar to the House-passed version.

April 13, 2007 | Daily News

Brand biologic drug makers are concerned a pending legislative proposal to create an approval pathway for generic biologic drugs would let FDA approve a biogeneric, or follow-on biologic, almost immediately after approving an application for a new biologic. Because biologic patents typically cover the manufacturing process, a generic maker who alters the process could circumvent the patent, the brand industry fears.

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