Login

Forgot password?
Sign up today and your first download is free.
REGISTER

Congress

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Several amendments by GOP members to narrow the scope of proposed FDA's authorities failed or were withdrawn during a marathon Senate health committee markup of sweeping FDA reform and user fee legislation Wednesday (April 18).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.

April 12, 2007 | Daily News

Consumer and patient advocacy groups Wednesday (April 11) urged Senate health committee Chair Edward Kennedy (D-MA) to tighten the advisory panel conflict of interest requirements in his drug user fee/FDA reform bill before it is marked up next week.

April 11, 2007 | Daily News

One day before Senate Finance Committee lawmakers will meet to hash out the details of Chairman Max Baucus' (D-MT) Part D negotiation bill, several key committee members indicated they will support the measure even though it doesn't go as far as they would like to promote government intervention. The members said they will move the bill through committee with intentions of strengthening it later.

"This is going to evolve as it goes through the floor, as it goes through conference," Finance Democrat Ron Wyden (OR) said Wednesday (April 11). "This is: Get it out of committee."

April 11, 2007 | Daily News

Senate health committee Chair Edward Kennedy (D-MA) introduced Tuesday (April 10) comprehensive FDA reform and prescription drug user fee legislation that includes drug safety provisions as well as pediatric research and exclusivity revisions that will serve as a foundation for legislation the health committee will mark up April 18. The bill does not include creation of a pathway for biogeneric approval, generic drug user fees or compounded drug reform.

April 10, 2007 | Daily News

The congressional debate on biogenerics is different from the early 1980s when lawmakers where creating a path for generic drug approval because both brand and generic drug makers had something they wanted and worked out a deal they presented to Congress, industry sources say. This time around, the brands and generics have not reached an agreement. Instead, Rep. Henry Waxman (D-CA) introduced legislation clearly worked out with only generic industry input.

Pages