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Rx Drugs

December 18, 2003 | Daily News

The Congressional Budget Office (CBO) has downgraded its projections of the ability of future Medicare prescription drug plans to contain drug costs because of provisions in the newly enacted law outlining beneficiary rights to appeal formularies, requiring drug plan and manufacturer disclosure of drug price concessions and reducing the risk borne by drug plans.

December 17, 2003 | Daily News

A drug industry representative contends that FDA will lose its credibility and authority if the agency does not stop states and cities from reimporting prescription drugs from Canada. The representative slammed states for insisting on reimportation as a solution for high drug prices and said their plans are not a long-term solution.

Reimportation is a gimmick and its supporters are engaging in political gamesmanship, the representative charged.

December 17, 2003 | Daily News

Vermont, one of the latest entrants into the prescription drug reimportation debate, is seeking FDA's approval to reimport cheaper prescription drugs from Canada for the state's employees. Under the state's proposed program, Canadian doctors would rewrite drug prescriptions as Canadian prescriptions after reviewing the patient's medical history. Licensed Canadian pharmacies could then fill these prescriptions and mail the drugs back to the patient in the United States.

December 16, 2003 | Daily News

Still struggling with a negative fiscal outlook, states are worried Medicare's new drug benefit could diminish their pharmaceutical purchasing power under Medicaid -- one of the states' major tools in their battle to lower prescription drug prices.

December 15, 2003 | Daily News

Technical corrections to the mammoth Medicare bill President Bush recently signed into law are unlikely to take place next year, according to GOP congressional aides.

Many industry sources and observers are widely speculating that a technical amendment package will be pursued next year, but GOP aides are downplaying the possibility. "We think there's got to be a year cooling off period at least," one Republican source aide, adding that it is premature to talk of a technical corrections bill so soon after the legislation was passed.

December 15, 2003 | Daily News

The decision by Medicare conferees not to subsidize certain state pharmaceutical assistance programs for delivering the Medicare drug benefit means state governments will likely have to push seniors to sign up for a confusing new Medicare drug plan even if they are enrolled in state programs that provide superior benefits.

The recently passed bill will allow state programs to "wrap-around" the gaps in the Medicare drug benefit, amounting to significant savings for the costly state programs -- assuming that seniors will switch over to it.

December 12, 2003 | Daily News

Key Democrats in the House and Senate who have opposed reimportation in the past are now pushing a more restrictive alternative that would allow reimportation from Canadian exporters inspected and certified by FDA. The move splits Sen. Edward Kennedy (D-MA) and Rep. John Dingell (D-MI) from Senate Minority Leader Tom Daschel (D-SD) and other Democrats who are pushing for broader reimportation.

December 12, 2003 | Daily News

Sen. Orrin Hatch (R-UT) is once again urging fellow lawmakers to debate a fast-track approval process for follow-on biologics. Hatch says that passage of the Medicare drug benefit will fuel the debate because policy makers now need to look for ways to contain costs of covering biotech products.

December 11, 2003 | Daily News

After two legal defeats, the Bush administration has rolled out its latest discount card plan to immediately lower Medicare beneficiaries drug costs -- this time with the legal authority a federal court twice said it lacked.

December 11, 2003 | Daily News

Sen. Orrin Hatch (R-UT) is criticizing the 180-day generic drug exclusivity section of the drug patent reform provisions passed as part of the Medicare drug benefit. Hatch is floating a draft he claims will help fix a new "loophole" created by the new law.

December 09, 2003 | Daily News

The Medicare bill's generous payment incentives for new regional preferred provider organizations (PPOs) will likely allow them to draw enrollees away from locally based HMOs, putting such pressure on these private plans that they may not be a viable alternative by the time a controversial 2010 demonstration program makes them compete head-to-head with fee-for-service Medicare, according to lawmakers and experts familiar with the industry.

December 08, 2003 | Daily News

In a win for the generic drug industry, the Supreme Court has refused to review a lower court ruling that brand-name drug firms must wait to sue if a company files a generic drug application and the only patents blocking the application are for an unapproved or "off-label" use. Brand-name drug company Allergan argued that allowing the decision to stand would chill research on new uses. The generic drug industry countered that a reversal would allow brand-name drug firms to unjustly delay competition.

December 08, 2003 | Daily News

The Congressional Budget Office predicts the cost of the Medicare prescription drug benefit signed into law by President Bush Dec. 8 will escalate rapidly after its $400 billion budget is used up in 2013, costing taxpayers more than $ 1 trillion over the subsequent 10 years as more Baby Boomers retire.

That projection is based on maintaining the current rate of increase in prescription drug costs and does not include any improvements in drug coverage, according to Douglas Holtz-Eakin, director of the Congressional Budget Office (CBO).

December 05, 2003 | Daily News

Medicare conferees adopted a strict prohibition against future determinations by CMS that competing drugs are functionally equivalent, choosing language from the Senate bill over the House bill's call for FDA to establish its own standard for when competing drugs have the same impact.

"It's a flat out ban," said a source with the Biotechnology Industry Organization (BIO), which had pushed for the Senate language.

December 04, 2003 | Daily News

Last-minute changes to the Medicare bill added $11 billion to the drug coverage for low-income beneficiaries, but Democratic critics charge the final legislation still falls short of the original Senate bill's low-income protections while sticking states with a permanent bill for Medicare's assumption of the low-income benefit. State lawmakers, who had sought a total buyout, are also upset.

December 03, 2003 | Daily News

Medicare conferees made last-minute concessions to minimize the effect of cuts in drug reimbursement for oncologists and other physicians, even as they extracted another $4.2 billion in savings by including inhalation drugs -- provided by major homecare companies -- in reform of the average wholesale price (AWP) drug payment system. President Bush plans to sign the mammoth Medicare bill Dec. 8.

November 26, 2003 | Daily News

Just hours after the Senate passed landmark Medicare reform legislation Nov. 25, Minority Leader Tom Daschle (D-SD) introduced his own bill to strip key provisions from the historic Medicare deal now heading to the president's desk. Daschle's bill aims to make prescription drugs more affordable by allowing the Medicare program to negotiate with industry for lower drug prices and letting Americans reimport U.S.-made drugs.

November 26, 2003 | Daily News

In the face of burgeoning federal deficits, Democrats and senior advocates are going to have a tough time trying to convince Congress to close the coverage gap in the new Medicare drug benefit that now awaits the signature of President Bush, according to lawmakers and experts on both sides of the debate.

November 25, 2003 | Daily News

A Minnesota state court judge wants more information from the attorney general's office and drug company GlaxoSmithKline before deciding if GSK should be forced to hand over documents about the firm's decision to block sales to Canadian pharmacies selling drugs to U.S. consumers. Meanwhile, the AG's office says not all drug importation is illegal and GSK cannot violate antitrust law to curb illegal imports.

The judge gave the two parties two weeks to submit more information, a source says.

November 25, 2003 | Daily News

Five months after the Senate overwhelmingly passed its own Medicare prescription drug bill, a compromise negotiated with House GOP leaders passed the Senate today (Nov. 25) by a much narrower margin as Democratic leaders railed against the inadequacy of the drug benefit and the bill's push for seniors to join private plans.

After Republican leadership was able to narrowly overcome House passed the conference report 220-215 after GOP leaders convinced colleagues to change their votes.