Login

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

Congress

July 26, 2007 | Daily News

Energy & Commerce Democrats Call For Ouster Of FDA Reg Affairs Chief

House Energy and Commerce Democrats are calling for FDA's top regulatory affairs official to be removed from her job or disciplined for what they view as retaliation against regional laboratory directors who raised questions about FDA's lab closure plan in congressional testimony. The lab closings are contentious, and HHS management has even tried to stop union members from sending e-mails describing congressional efforts to block FDA laboratory closings.

July 26, 2007 | Daily News

The debate on FDA granting conflict-of-interest waivers to external advisory panel members is gaining traction as the House and Senate prepare to go to conference on their FDA drug safety bills. A health care coalition is lobbying lawmakers to maintain Senate language that gives FDA greater flexibility to grant waivers, while consumer groups and other patient groups prefer House language that limits a waiver to one per panel.

July 26, 2007 | Daily News

The American Academy of Pediatrics is asking House and Senate lawmakers to hammer out in conference new language for several pediatric-related provisions in their FDA bills. AAP opposes the Senate bill's sunset provision on a pediatric medical device research law and a provision that limits extended testing of pediatric studies. AAP also wants struck House language that extends market exclusivity protection.

July 26, 2007 | Daily News

Former CMS Administrator Mark McClellan defended the Bush administration for allowing states to cover adults under the State Children's Health Insurance Program (SCHIP), but noted that CMS has been pushing states to transfer these adults into Medicaid after statutory changes made Medicaid coverage expansions easier.

Democrats have recently taken heat from Republicans for suggesting that SCHIP should continue to cover certain adults, even though it was a GOP administration that -- partly under McClellan -- allowed the SCHIP coverage expansions in the first place.

July 26, 2007 | Daily News

Just a day after House Democratic leaders proposed to drop Medicare's rental cap on oxygen equipment, the oxygen lobby is blasting the move as a potential burden to patients that could harm access and safety. The proposed ceiling is expected to save Medicare about $2.8 billion over the next five years, according to an early analysis from the Congressional Budget Office.

July 26, 2007 | Daily News

After two days of arguing, the Senate health committee postponed until Aug. 1 marking up tobacco legislation to review a slew of amendments. The bill has stayed largely intact, with the addition of provisions that require graphic and larger text warnings on cigarette packs and let cigar and pipe tobacco manufacturers delay paying user fees.

The committee also accepted a technical amendment by Sen. Johnny Isakson (R-GA) on how excise taxes are charged for different tobacco products.

July 25, 2007 | Daily News

In the run-up to floor action on the Senate's bipartisan SCHIP legislation, GOP opponents of the $35 billion bill are urging their Republican colleagues to support a market-based alternative that would limit eligibility to children and pregnant women below 200 percent of the federal poverty level (FPL) and eliminate the waivers that have allowed states to expand their coverage populations.

July 25, 2007 | Daily News

Two key senators questioned the administration's nominee to head the Office of Management and Budget on the agency's role in federal agencies' rulemaking process as a controversial executive order giving the White House greater influence over regulatory activity became fully effective Tuesday (July 24).

July 25, 2007 | Daily News

The Senate health committee amended tobacco legislation to require graphic warnings on cigarette packs along with larger print text warnings. The committee also passed an amendment letting cigar and pipe tobacco manufacturers delay paying user fees.

The committee began considering legislation that would give FDA regulatory authority over tobacco (S.625) Wednesday (July 25), but delayed a vote until Thursday after losing a quorum.

July 25, 2007 | Daily News

Suppliers of durable medical equipment (DME)-- frustrated in recent months over what they say are numerous glitches in CMS' new competitive bidding initiative-- got a big boost last week when the Senate's leading Medicare voices urged a three-month extension for the registration and bid-submission deadlines surrounding the program. Registration for DME suppliers ended July 7, and bids are due Friday (July 27).

July 25, 2007 | Daily News

President Bush's nominee to take control of CMS Wednesday (July 25) indicated that, if confirmed, a top priority would be to smooth data transfer issues between CMS and the Social Security Administration that caused problems with seniors' Part D premiums being withheld. Kerry Weems, a 24-year veteran of public service and current deputy chief of staff for HHS Secretary Michael Leavitt, also told the few Senate Finance members who attended the two-hour confirmation hearing that he had "no intention" of using his office for political purposes.

July 25, 2007 | Daily News

Final details of a $90 billion, multi-pronged House bill that would reauthorize the State Children's Health Insurance Program (SCHIP) for five years, extend coverage to a total of 11 million children, block a 10 percent cut to physicians and beef up the Part D low income subsidy (LIS) program emerged last night as Democrats now try and move the package out of committee and onto the floor prior to the August recess.

July 24, 2007 | Daily News

AARP and the American Medical Association (AMA) are jointly sponsoring a nationwide advertising campaign touting House Democrats' plan to expand the State Children's Health Insurance Program (SCHIP) and boost Medicare payments to doctors by increasing cigarette taxes and cutting the Medicare Advantage program while protecting beneficiaries from increases in Part B premiums.

July 24, 2007 | Daily News

CMS and lawmakers are taking steps to address providers and pharmacists' concerns with a congressional mandate that all prescriptions for Medicaid patients to be written on tamper-resistant prescription pads by Oct. 1. CMS will soon release guidance that aims to ensure implementation hurdles don't cut-off patients' access to drugs, a move called for by lawmakers who are also pushing legislation to limit the scope of the tamper-resistant requirement.

July 24, 2007 | Daily News

House Democrats have cut their proposed 61-cent per pack cigarette tax -- the primary funding mechanism for the Children's Health and Medicare Protection (CHAMP) bill -- down to 45 cents to assuage conservative-leaning Blue Dog Coalition members, a House staffer confirmed Tuesday morning, raising concerns among medical specialty lobbyists the legislation to be marked up Wednesday may also cut back a planned physician payment fix.

July 23, 2007 | Daily News

Rep. Mark Kirk (R-IL) introduced bipartisan legislation that would give FDA $20 million in additional appropriations for each fiscal year through 2012 for increased inspections of imported processed food and toothpaste. The bill, introduced July 19, also raises civil penalties for importing adulterated food more than $79 million above the current fees.

A Kirk spokesperson says he is talking with House Energy and Commerce Committee staff to "move forward on the issue." Bill cosponsors are Reps. Rick Larsen (D-WA) and Patrick Kennedy (D-RI).

July 23, 2007 | Daily News

America's Health Insurance Plans' (AHIP) six-point campaign to mobilize seniors to speak out against cuts to the Medicare Advantage (MA) program is viewed by House Ways & Means leaders as an attempt to manipulate seniors in a bid to protect managed care plan profits, a committee aide said. AHIP stepped up its grassroots drive last week as the country's largest seniors group, AARP, joined forces with the powerful physician lobby to support House Democrats' plan to shave back MA payments.

July 23, 2007 | Daily News

House Energy and Commerce oversight subcommittee Chair Bart Stupak (D-MI) introduced legislation Monday (July 23) that would require fresh meat, seafood and poultry packaged with carbon monoxide to be labeled as such. The bill was cosponsored by Reps. Edward Markey (D-MA) and Rosa DeLauro (D-CT).

The labeling requirement will likely be included in broader food safety legislation the committee is expected to introduce this week, a source tells FDA Week (see related story).

July 20, 2007 | Daily News

After the Senate health committee pushed back marking up tobacco legislation to next Wednesday (July 25), the committee's ranking Republican, Michael Enzi (WY), proposed his own bill. Instead of making FDA regulate tobacco, a core element in committee Chair Edward Kennedy's (D-MA) tobacco bill, Enzi wants to ban nicotine.

Kennedy's bill was scheduled for markup July 18, but it was delayed because of the overnight Senate debate on the Iraq war.

July 20, 2007 | Daily News

House Democrats this week used a food oversight hearing to lambaste FDA for allowing meat and seafood to be treated with carbon monoxide to make it look fresh longer.

Pages