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Congress

March 08, 2007 | Daily News

Pharmacies are protesting a draft bill on pharmacy compounding they say is a short step away from giving FDA authority to regulate off-label prescribing. The draft bill, by Senate health committee chair Edward Kennedy (D-MA), would require doctors to document when compounded medications are needed, which pharmacies argue duplicates the purpose of a prescription, and also would give FDA the authority to determine when compounded drugs are needed.

March 07, 2007 | Daily News

Senate Special Committee on Aging Ranking Republican Gordon Smith (OR) has positioned himself as a power-broker who might be able to help Democrats shepherd Medicare Part D "fixes" through the upper chamber. The soft-spoken lawmaker is working with Democrats on legislation to streamline Part D and simplify the low-income subsidy (LIS) application process.

March 07, 2007 | Daily News

Sen. Christopher Dodd (D-CT) may reintroduce legislation that aims to boost development of pediatric devices as early as this week, according to a source following the matter. Industry representatives hope this year's bill will eliminate a measure from last year's version allowing FDA to require post-market clinical trials for pediatric devices once they are on the market -- but it is unclear if industry will get its way.

Rep. Ed Markey (D-MA) plans to introduce sister legislation in the House, according to Markey's office.

March 07, 2007 | Daily News

House Energy & Commerce health subcommittee Chair Frank Pallone (D-NJ) will attempt to propose a long-term policy to replace the sustainable growth rate formula (SGR) during this Congress and will turn to Medicare Advantage funding to pay for it, he told reporters this week.

March 06, 2007 | Daily News

A coalition of generic drug makers, insurers, pharmacy benefit managers and employers met Monday (March 5) with the Congressional Budget Office to answer questions the nonpartisan economic analysts had regarding biogenerics, an industry source with direct knowledge of the meeting said.

The Biotechnology Industry Organization (BIO) also has met with CBO but would not comment on the meeting. BIO takes more of a brand biologic industry stance on biogenerics even though its membership includes companies interested in making biogenerics.

March 06, 2007 | Daily News

Senate Finance Chair Max Baucus (D-MT) Tuesday stressed the need for a "far-looking approach" and called for $50 billion over five years to cover all children currently eligible for the State Children's Health Insurance Program (SCHIP).

March 06, 2007 | Daily News

The House Oversight and Government Reform Committee has set its sights on drug and device manufacturers that hawk their products for uses not approved by FDA, an illegal practice known as off-label promotion.

March 05, 2007 | Daily News

The chair of the House appropriations subcommittee with jurisdiction over FDA's budget strongly opposes the agency's proposal to collect industry user fees to support reviews of drug ads voluntarily submitted by companies. The lawmaker wants FDA to impose mandatory reviews that cover both television and Internet advertising.

Rep. Rosa DeLauro (D-CT) said Feb. 28 at an Appropriations agriculture subcommittee hearing that the proposal ties FDA's hands and does nothing to gain the public's trust in FDA's oversight of drug advertising.

March 05, 2007 | Daily News

This year's drug user fee reauthorization bill may evolve into an omnibus FDA reform measure as lawmakers and stakeholders increasingly view the "must-pass" measure as their best bet for getting long-sought myriad reforms through Congress, sources say.

Drug safety legislation has long been expected to accompany PDUFA, but the list of potential riders is growing:

March 05, 2007 | Daily News

Senate health committee leaders plan to use a hearing Thursday (March 8) on biogenerics to flesh out an alternative to already introduced legislation that would create an approval pathway for biogenerics, health committee ranking Republican Mike Enzi's (WY) office confirmed.

Former FDA employees and a European regulator are scheduled testify at the biogenerics hearing, according to a source with access to the hearing's witness list, which has not been released publicly.

March 02, 2007 | Daily News

Senate Finance Democrat Jeff Bingaman (NM) reintroduced legislation Thursday (March 1) that would establish federal grants for state Medicaid and SCHIP programs to provide dental care to low-income children. The move comes as congressional Democrats are already struggling to find ways to pay for what promises to be an expensive renewal of the popular State Children's Health Insurance Program, which expires Sept. 30.

Sponsors of the legislation say it's worth the cost.

March 02, 2007 | Daily News

Acting CMS Administrator Leslie Norwalk indicated Friday (March 2) the agency may be willing to provide Medicare Part D rebate data to the Government Accountability Office for its confidential use, a day after refusing to release it to House Government Reform and Oversight Committee ranking Republican Thomas Davis (VA). The move increases pressure on committee chair Henry Waxman (D-CA) to withdraw a similar data request to Part D sponsors and achieve a compromise with Republicans that ensures proprietary information will not be disclosed.

March 01, 2007 | Daily News

An influential Texas House member is taking the reins on legislation that would steer the state Children's Health Insurance Program (SCHIP) back to its original intent of covering low-income children by explicitly prohibiting CMS from allowing state enrollment of non-pregnant adults in the federal program and requiring already approved state waivers to be revoked.

February 28, 2007 | Daily News

House Energy and Commerce Committee Republican leaders are asking why FDA drug center officials are not listing their meetings with stakeholders on the agency's public calendar as required by law, leaving lawmakers to wonder what FDA is hiding.

The public calendar review was sparked by meetings between the drug industry and FDA regarding the antibiotic Ketek that Energy and Commerce staff were informed were held but are missing from public calendar listings, according to a congressional source.

February 28, 2007 | Daily News

House Appropriations Chair David Obey (D-WI) put HHS Secretary Michael Leavitt on notice Tuesday (Feb. 27) that Democrats will use the Iraq War supplemental spending package as a vehicle to appropriate at least $750 million to fill short-term SCHIP funding gaps faced by over a dozen states.

Obey, who also chairs the Appropriations Labor/HHS subcommittee, told Leavitt the extra money is needed so states "don't rip those kids off the rolls." The emergency supplemental budget request would not be subject to pay-go rules.

February 28, 2007 | Daily News

Federal Reserve Chairman Ben Bernanke told House lawmakers Wednesday that the rising cost of entitlement spending -- particularly in the areas of Medicare and Medicaid -- will drown the national economy within just a few decades unless Congress takes early steps to rein it in.

February 27, 2007 | Daily News

Sen. Gordon Smith (R-OR) this week announced support for a broad expansion of the state children's health insurance program (SCHIP) to cover both children and pregnant women up to 300 percent of the federal poverty level (FPL), proposing to pay the freight with a hike on the federal tobacco tax. Smith said he has "reason to believe" Senate Finance Chair Max Baucus (D-MT) will back the idea, but Baucus hedged questions on the issue.

February 27, 2007 | Daily News

Senate health committee chair Edward Kennedy (D-MA) said Tuesday (Feb. 27) he plans to mark up legislation before summer that would give FDA authority to regulate tobacco products despite opposition to the bill expressed by the committee's top Republican at a health committee hearing the same day. FDA Commissioner Andrew von Eschenbach also refused to endorse the tobacco measure at another hearing on Tuesday.

February 27, 2007 | Daily News

Senate Finance and House Ways & Means leaders Tuesday called for congressional intervention into CMS' oversight of specialty hospitals despite the agency's attempt to assuage their concerns about its handling of a Texas specialty hospital where a patient died following elective surgery.

February 26, 2007 | Daily News

Rep. Edward Markey (D-MA) reintroduced Feb. 16 his legislation aimed at reforming drug safety efforts at FDA with some additional provisions not included in last year's bill that aspire to increase transparency at the agency and shore up the agency's advisory panel procedures.

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