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Rx Drugs

October 24, 2003 | Daily News

FDA for now is not going after Springfield, MA, for reimporting drugs from Canada because the agency wants to first win its case against Rx Depot, giving FDA bargaining power for the more difficult task of taking formal action against states and local governments from doing likewise, according to FDA and industry sources.

FDA is proceeding cautiously to regain the authority that has atrophied over years of not strictly enforcing the reimportation law, according to an industry source. An FDA source also points to the enormous resource burden involved in suing states.

October 24, 2003 | Daily News

Medicare conferees Oct. 24 broke off negotiations until after the weekend, missing their second target date for agreement in as many weeks amid a partisan stand-off on the House bill's plan to put Medicare in competition with private plans.

Nevertheless, Ways and Means Committee Chairman Bill Thomas (R-CA) said the conference would reach a conceptual agreement by the middle of next week and emphasized there would be no renegotiation of this deal once it is settled.

October 23, 2003 | Daily News

Following on the footsteps of Massachusetts' attorney general, members of the state's congressional delegation are pressing FDA to explain its concerns over the reimportation of prescription drugs from Canada and outline agency plans to ensure the safety and effectiveness of such drugs.

October 23, 2003 | Daily News

Medicare conferees have agreed to embrace the Senate bill's government-sponsored fallback drug plan but have decided to adopt the House bill's trigger for its use, making it less likely that the fallback will be implemented, according to informed sources.

October 23, 2003 | Daily News

On the eve of a targeted Medicare conference deadline, a tripartisan group of Senate lawmakers have called on President Bush to support a bipartisan conference bill and have outlined issues they say must be addressed to gain their support. The move signals troubled waters for the conference bill as the issues the senators oppose are key provisions Medicare conference chair Bill Thomas (R-CA) reportedly is advocating in a closely held draft proposal.

October 23, 2003 | Daily News

The Department of Justice has signed off on new drug patent reform language that erases DOJ's constitutionality concerns with the "declaratory judgment" provision included in the Senate Medicare bill. The proposed declaratory judgment compromise is now being reviewed by Medicare conferees.

October 21, 2003 | Daily News

Medicare conferees are considering a prescription drug benefit that combines more generous coverage for drug expenses under $2,200 -- the House bill's plan to target the benefit towards the level of drug expenses incurred by most seniors -- with subsidies for low-income beneficiaries like those found in the Senate bill.

October 20, 2003 | Daily News

Massachusetts Attorney General Thomas Reilly is asking FDA why the agency is not willing to implement existing law that would allow pharmacists and wholesalers to reimport drugs, but only if FDA provides a certification it has repeatedly refused to give. Reilly urges FDA to implement existing law and issue regulations to ensure safety of imported prescription drugs.

October 20, 2003 | Daily News

Key senators involved in the Medicare conference are looking to wrap up a deal this week in order to allow sufficient time to complete legal drafting and obtain cost projections on the mammoth prescription drug legislation in advance of votes by both chambers in early November.

October 15, 2003 | Daily News

Medicare conferees are considering a plan to supplement proposed subsidies for retiree drug coverage with a tax credit to encourage employers to maintain coverage, lawmakers and private sector sources said.

"Tax credits, incentives are probably the way it's going to go," House Energy and Commerce health subcommittee chairman Michael Bilirakis (R-FL) said prior to the Sept. 30 meeting of conferees.

October 15, 2003 | Daily News

Senate staff is floating a new proposal on declaratory judgment -- one of the most controversial drug patent reform issues in the Medicare drug benefit legislation -- in a bid to address concerns that the Senate-passed provision is unconstitutional, according to a drug industry source. The compromise is being discussed as part of the conference discussions on the Medicare bill.

October 14, 2003 | Daily News

The target date for passage of a Medicare conference report has been pushed back to the end of the month, with the final provider package expected to be one of the last issues resolved, according to industry and congressional sources.

"The goal is to get it done by the end of the month," Ways and Means Committee member Rep. Paul Ryan (R-WI) said during an Oct. 7 Galen Institute forum. That deadline could still slip, Ryan cautioned, but noted further delays would cut into the November congressional recess and meetings scheduled with constituents.

October 14, 2003 | Daily News

In an effort to curb counterfeit-drug imports, the Department of Justice is advising lawmakers that they could change food and drug law to make it easier for FDA to investigate and prosecute foreign companies. In a letter to House Energy and Commerce Committee lawmakers, DOJ writes that Congress could give FDA the explicit authority to secure documents and interviews with witnesses, independent of an inspection.

October 10, 2003 | Daily News

A prominent House conservative this week urged his wing of the GOP to remain engaged in the Medicare negotiations, warning that simply opposing a new $400 billion drug benefit could kill prospects for wider Medicare reform in the House bill and doom the program to insolvency.

October 10, 2003 | Daily News

Medicare conferees are considering expanding CMS' Center for Beneficiary Choices (CBC) so it can administer Medicare's prescription drug benefit and private plans instead of creating a new HHS agency to do the job, according to informed sources.

The idea is to have a beefed-up CBC gradually assume the new function. It would build upon CBC's existing infrastructure rather than establish an entire new agency by early next year as called for under the House and Senate plans.

October 10, 2003 | Daily News

Justice Department lawyers finished their arguments for a preliminary injunction against Rx Depot and Rx of Canada Thursday morning, though the judge did not rule on the motion. Both sides have until Oct. 31 to submit proposed findings of fact and conclusions of law, after which the judge plans to quickly issue a written order.

October 09, 2003 | Daily News

Medicare conferees have reopened an agreement in principle reached last week to extend Medicare prescription drug coverage to beneficiaries who are also Medicaid eligible, pending agreement on how to claw back more of the savings from state Medicaid programs and how the change would affect benefits for the near-poor, advocates and congressional sources said.

October 09, 2003 | Daily News

In an unexpected result, the House this week soundly rejected a Republican motion instructing Medicare conferees to use means testing to help defray the cost of Congress' prescription drug bill. The defeat comes as Medicare conferees mull proposals to charge wealthier beneficiaries more under Medicare.

October 08, 2003 | Daily News

FDA has contracted with the New Mexico State University to develop a risk-based automated drug import examination system that would allow the agency to determine which imports need to be targeted for risky drugs, a university source says. The automated system would process huge amounts of data culled from various sources to predict which imports are most likely to contain counterfeit or unapproved drugs, the source says.

October 07, 2003 | Daily News

FDA is asking lawmakers negotiating a drug patent reform deal as part of the Medicare reform conference talks to ensure that provisions limiting treble damages and allowing innovators to view a generic applicant's confidential data do not impose new burdens on the agency, according to FDA Chief Counsel Dan Troy. The agency is also asking the conferees to change the effective date of the 30-month stay provision.

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