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Congress

September 21, 2007 | Daily News

FDA advisory committees will soon have to begin to ween themselves of experts with financial conflicts of interest. A compromise brokered by congressional staff calls for incremental reductions in the number of experts who receive conflict-of-interest waivers, putting to rest one of the most closely contested battles involved in merging the House and Senate FDA reform bills.

September 21, 2007 | Daily News

Reps. Henry Waxman (D-CA) and Anna Eshoo (D-CA), as well as several pediatric organizations, blasted the sunset on pediatric medical device research law included in the final FDA bill that Congress passed Thursday (Sept. 20). The lawmakers offered different opinions, though, on the bill's provision giving makers of "blockbuster" drugs researching their products on children six months of additional market protection, instead of three months as proposed by the Senate.

September 21, 2007 | Daily News

Congressional staff used the House version of FDA drug safety legislation as the backbone for their conference agreement by separating FDA authority to impose post-market clinical trials and studies from authority to impose a risk evaluation and mitigation strategy (REMS).

September 21, 2007 | Daily News

The FDA bill passed by Congress this week gives HHS three years to figure out whether it is feasible to publish lay summaries of clinical trial results and gives the National Institutes of Health three years to write regulations implementing a technical results database. Consumer groups consider the measure a win because the White House tried at the last minute to eliminate the results database.

September 21, 2007 | Daily News

Several strong antibiotics provisions are included in the FDA Amendments Act passed this week by Congress, but just hours before voting on the bill House lawmakers removed a Senate provision that would have granted new market exclusivity to some antibiotics.

The Senate passed the identical bill by unanimous consent Thursday evening.

September 21, 2007 | Daily News

The heated, protracted fight that delayed for hours a Senate vote on FDA reform legislation Thursday (Sept. 20) was, in some long-ago sense, about FDA preemption of state tort suits. Although lawmakers spent the last several days squabbling primarily about how that section of the FDA bill was handled politically, they also spent months debating the policy itself. The Senate ultimately passed the bill, but lawmakers are still complaining about the preemption language.

September 21, 2007 | Daily News

The compromise FDA legislation that Congress passed this week has big wins and losses for both Republicans and Democrats.

Republicans fought off attempts to cut pediatric exclusivity in half for blockbuster drugs and to make permanent a law that lets FDA force pediatric research when the market exclusivity is not enough of an incentive to get companies to study their products on children.

September 21, 2007 | Daily News

The Bush administration did not politically manipulate a report examining the effects of the State Children's Health Insurance Program (SCHIP) on the private insurance market, the lead researcher of the contracted study said this week, disputing charges by key House and Senate Democrats that CMS removed language it didn't like. The researcher acknowledged, however, that after meeting with CMS, the contractor revised certain conclusions about "crowd out" to emphasize a broad range of findings.

September 21, 2007 | Daily News

House and Senate Democratic leaders, with the input of key Senate Republicans, finalized a five-year, $35 billion plan to expand the State Children's Health Insurance Program (SCHIP) Friday (Sept. 21), a deal that mimics an earlier-approved Senate proposal but also includes language providing basic dental services, mental health parity, and early periodic screening, diagnostic and treatment.

September 20, 2007 | Daily News

The Senate Tuesday (Sept. 18) evening approved a mental health parity bill for private insurers under a unanimous consent amendment, paving the way for action in the House on a similar, but not identical, piece of legislation.

According to Sens. Pete Domenici (R-NM) and Edward Kennedy (D-MA), the Mental Health Parity Act (S.558) will expand coverage to more than 113 million patients who suffer from some form of mental illness or substance addiction.

September 20, 2007 | Daily News

President Bush Thursday morning reiterated his veto threat of pending SCHIP reauthorization legislation and urged Congress to pass a short-term extension. Minutes later, HHS Secretary Michael Leavitt said the administration has the votes in Congress to sustain a veto. Leavitt also appeared to back a new bill, to be dropped today by Rep. Joe Barton (R-TX), that would extend the program for 18 months.

September 20, 2007 | Daily News

The Senate quickly passed the biggest overhaul of FDA law in at least five years Thursday evening (Sept. 20) after Sens. Richard Burr (R-NC) and Tom Coburn (R-OK) dropped their holds on the bill.

Burr and Coburn held up the legislation because they were angry that House staff did not include the Senate in last-minute revisions that the senators say make it easier for trial lawyers to sue drug makers.

Sources said multiple senators had placed holds on the FDA bill. Holds do not have to be disclosed, making it unclear whether other senators were also involved.

September 19, 2007 | Daily News

House and Senate Democrats have reached a deal on SCHIP that closely mirrors the Senate's $35 billion expansion proposal but also includes a few dental and mental health-related Medicare and Medicaid provisions pushed under the House proposal, House Speaker Nancy Pelosi's (D-CA) health advisor told health advocates Wednesday.

Wendell Primus, Pelosi's health advisor, told hundreds of health care advocates in a Capitol briefing that GOP Sens. Charles Grassley (IA) and Orrin Hatch (UT) have signed off on the compromise.

September 19, 2007 | Daily News

The House on Wednesday (Sept. 19) passed FDA legislation by a vote of 405-7 after House and Senate staff reached a compromise earlier in the morning. The Senate is expected to vote on the compromise user fee/drug safety legislation by Thursday.

The staff agreement allows the two chambers to sidestep formal congressional conference deliberations in a bid to get a user fee reauthorization bill to the president's desk in time to avoid 2,000 FDA layoff warning notices (see related story).

September 19, 2007 | Daily News

The nation's most powerful seniors and physician lobbies, upset that physician payment relief is not part of Congress' expected deal on the children's health care program, is stepping up efforts to get lawmakers to address the issue. The groups on Tuesday (Sept. 18) offered tempered praise for Congress' expected SCHIP deal, but also urged lawmakers to act quickly to protect physicians from the Medicare payment reductions that will hit on Jan. 1 without a legislative fix.

September 19, 2007 | Daily News
The compromise FDA legislation passed by the House Wednesday (Sept. 19) has big wins and losses for both Republicans and Democrats.

Republicans fought off attempts to cut pediatric exclusivity in half for blockbuster drugs while making permanent a law that lets FDA force pediatric research when the market exclusivity is not enough of an incentive to get companies to study their products on children.

September 19, 2007 | Daily News

House investigators who analyzed the government's handling of the tuberculosis scare in May are urging the Centers for Disease Control and Prevention to shift some of its bioterrorism agent testing technology to state labs that regularly test for TB.

September 18, 2007 | Daily News

Using the tax code to deter direct-to-consumer drug advertising would be unconstitutional several times over, a former FDA lawyer said in response to legislation by Rep. Pete Stark (D-CA) to tax certain DTC ads.

Arnold Friede, a former FDA assistant chief counsel, and John Kamp, an attorney at Wiley Rein, wrote in a Sept. 7 opinion that Stark's proposal runs afoul of both free speech and due process protections in the Constitution. Stark has previously defended the bill against First Amendment criticisms.

September 18, 2007 | Daily News

Panelists at a Senate Judiciary Committee hearing last week pressed Congress to require that FDA and other federal agencies consult state and local governments when they think regulations preempt state rules. Democratic and Republican lawmakers did not say they would propose legislation, but said they are keeping tabs on two important preemption lawsuits, one of which the U.S. Supreme Court has taken up, the other that the court is expected to take up.

September 18, 2007 | Daily News

Patient advocates and manufacturers are urging lawmakers to tweak House-passed comparative effectiveness language so that a planned research center does not take into account cost-effectiveness, maximizes stakeholder input and prevents Medicare and other payers from using findings to deny coverage. The stakeholders are concerned that boosting comparative effectiveness research, which is widely touted as key to improving clinical care and reducing spending, will come back to haunt beneficiaries who depend on treatments found to be less effective than others for the general public.

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