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Rx Drugs

November 18, 2003 | Daily News

GlaxoSmithKline is using federal law to defend itself against the Minnesota attorney general's charges that the firm violated state antitrust law by blocking sales to Canadian pharmacies selling drugs to U.S. consumers. Under federal law, importing drugs from Canada is illegal and a drug company can take steps to stop illegal sales of its products, according to GSK. Federal law pre-empts the attorney general's action, the company adds.

November 18, 2003 | Daily News

Congressional staffers have gotten over the last major hurdle of the drug-patent reform section in the Medicare bill by agreeing to report language on the declaratory judgment provision, according to congressional and industry sources. At issue was the constitutional standard for when a generic drug company could bring a declaratory judgment action to get a troublesome patent out of the way.

November 17, 2003 | Daily News

In a politically momentous move, AARP has officially declared its support for the tentative Medicare agreement hammered out by conferees, simultaneously handing proponents of the legislation much-needed leverage and reversing its recent track record of non-committal stances on Medicare legislation. The endorsement, however, has drawn both criticism and praise from opposing sides of the aisles.

November 17, 2003 | Daily News

Health Canada officials are asking FDA to share evidence showing that unsafe drugs are being shipped from Canada to the United States, a Canadian source says. Canadian health officials have found no evidence so far that unsafe drugs are being sold in Canada, the source says. Health Canada also has written to Canadian medical and pharmacy associations asking them to report risks to the Canadian drug supply, and warning of possible inspections.

November 17, 2003 | Daily News

FDA plans to sign a memorandum of understanding with Health Canada tomorrow (Nov. 18) calling for the two agencies to share information on Internet pharmacies selling drugs to U.S. consumers, an FDA official says. The MOU will also call for the two parties to share information on postmarketing surveillance of drugs, a Canadian source told FDA Week.

November 17, 2003 | Daily News

The Medicare conference agreement struck over the weekend leaves open the exact amount oncologists will be reimbursed for outpatient drugs and how much their practice expense payments will be raised to compensate for the cuts to the average wholesale price (AWP) reimbursement scheme.

The summary

November 14, 2003 | Daily News

House Energy and Commerce Committee ranking member John Dingell (D-MI) is asking Congress' investigative arm to study if the agencies responsible for safeguarding the nation's drug supply are doing an adequate job of controlling the entry of illegal drugs via the mail. Dingell wants to know if the various agencies, including FDA, have a comprehensive written plan to deal with the increasing number of illegal drugs coming into the country.

November 14, 2003 | Daily News

Democrats yesterday (Nov. 13) criticized the AARP for its acceptance of a demonstration program as a compromise on the controversial premium support issue and rallied other seniors groups to the Capitol to show their continued opposition to any version of it.

At the event, Sen. Chris Dodd (D-CT) said, "This is not a pilot program. This is a nationwide plan affecting a quarter of American seniors and…could be the beginning of the end of Medicare."

November 13, 2003 | Daily News

Congressional leadership has gone over the heads of Medicare conferees and forged a compromise that could bring support from moderate Senate Democrats, Tom Grissom, director of the Center for Medicare Management at CMS, said today (Nov. 13).

"Republican leadership of both the House and Senate have taken away the bill from the members of the conference committee," Grissom said at a drug industry conference.

November 13, 2003 | Daily News

Medicare conferees, including House Ways and Means Chairman Bill Thomas (R-CA), are set to resume negotiations on a prescription drug bill today (Nov. 13). Conferees also met last night, according to a source, just hours after a spokesperson for Thomas said he was flying home to California (see related story). Thomas' aborted walkout followed news that GOP congressional leaders had hashed out a compromise deal with the conference's only two Democrats.

November 13, 2003 | Daily News

Medicare negotiations have again broken down after conferees failed to reach agreement Nov. 13 on how to test-run direct competition between traditional Medicare and private plans. GOP leaders will now make another stab at resolving the contentious premium support issue and present their recommendations to the conference committee early next week.

November 12, 2003 | Daily News

House Ways and Means Committee Chairman Bill Thomas (R-CA) skipped town today (Nov. 12), canceling a meeting of Medicare conferees that would likely have forced a showdown on a compromise engineered last night by GOP congressional leaders and Sens. John Breaux (D-LA) and Max Baucus (D-MT).

November 12, 2003 | Daily News

New report language on one of the core provisions of the drug-patent reform section of Medicare legislation has the generic drug industry and key Senate Democrats up in arms. The generic drug industry supports bill language on the "declaratory judgment" provision, but industry believes that the report language -- normally of lesser importance -- would actually put generic drug companies in a worse position than they already face, according to a letter from the Generic Pharmaceutical Association (GPhA).

November 12, 2003 | Daily News

Consumers trying to find cheaper drugs would be better off buying generic drugs instead of traveling to Canada for brand name drugs, according to a key FDA official. Generic drugs are cheaper here than in Canada, the source says, and consumer groups should advocate generics instead of pushing for reimportation legislation.

November 11, 2003 | Daily News

Senate Majority Leader Bill Frist (R-TN) has signaled that he and House Speaker Dennis Hastert (R-IL) may weigh in to help resolve outstanding issues Medicare conferees cannot reconcile.

Speaking to reporters yesterday (Nov. 10), Frist indicated the degree of leadership involvement depends on how far negotiations get. "It's not like [we're saying] settle everything you can and bring what's left to us and we'll decide. It could be that, but that's not the way I view it."

November 11, 2003 | Daily News

Ten House Republicans crossed party lines last week and voted to instruct Medicare conferees to reject the House bill's controversial premium support provisions and instead boost physician payments or funds for hospitals serving the poor.

But for at least two of the lawmakers, their votes were prompted more by support for the provider issues than opposition to premium support.

The House voted on two motions calling for conferees to shoot down the House premium support provision, and both failed.

November 11, 2003 | Daily News

Health Canada officials are asking FDA to share evidence showing that unsafe drugs are being shipped from Canada to the United States, a Canadian source says. Canadian health officials have found no evidence so far that unsafe drugs are being sold in Canada, the source says. Health Canada also has written to Canadian medical and pharmacy associations asking them to report risks to the Canadian drug supply, and warning of possible inspections.

November 11, 2003 | Daily News

Medicare conferees will likely keep in place a requirement that HHS certify the safety and cost savings of allowing pharmaceuticals to be reimported from Canada, a procedure that has so far prevented legal access by consumers and pharmacies to cheaper drugs from Canada and other industrialized countries.

November 11, 2003 | Daily News

Medicare conferees meet at 11 a.m. Wednesday to decide whether they can individually sign off on a deal they discussed tonight (Nov. 11) that could potentially bring consensus on the three, most-divisive partisan issues in the conference report. Senate Finance Committee Chairman Chuck Grassley (R-IA) told reporters after tonight's meeting that the deal would include some version of all three of the controversial GOP-backed provisions -- a cap on Medicare spending, competition between Medicare and private plans, and tax breaks for health savings accounts.

November 10, 2003 | Daily News

CMS Administrator Tom Scully is encouraging state Medicaid directors to take a tough stance to counter the effects of direct-to-consumer advertising and promote generics as a way to bring down Medicaid drug spending.

Citing Nexium and its cheaper equivalents as examples, the CMS chief told a gathering of state Medicaid directors Oct. 28 that it "drives me crazy" that Medicaid spends $250 million on the brand drug when other alternatives are "virtually the same" thing.

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