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Rx Drugs

January 22, 2003 | Daily News

The fate of the Medicare drug discount card -- a cornerstone of the Bush administration's prescription drug agenda to date -- will be played out in a federal district courtroom Jan. 29.

In what could be the defining hearing on the case, pharmacy groups contesting the administration's latest card plan and the Department of Justice (DOJ) will both present arguments calling on the U.S. District Court for the District of Columbia to make a ruling on the case.

January 21, 2003 | Daily News

A freshman House member is drafting legislation to replicate Maine's pioneering Maine Rx law on a nationwide basis. Rep. Michael Michaud (D-ME) announced plans Jan. 21 to create "America Rx," a national initiative to rein in pharmaceutical costs for residents without drug coverage.

January 17, 2003 | Daily News

The United States has publicly outlined a series of conditions that must be met in order for it to continue its unilateral moratorium on mounting legal challenges in the World Trade Organization against countries that export generic copies of patented drugs to treat serious infectious epidemics.

January 17, 2003 | Daily News

Prospects appear dim for a new European Union initiative to break a deadlock on World Trade Organization talks on access to medicines, as developing countries, the World Health Organization and health activists criticized last week's proposal by the EU to allow the WHO to decide what diseases should be covered beyond an initial list of 23 infectious diseases.

January 16, 2003 | Daily News

A joint state cooperative developed to tackle soaring prescription drug prices is extending its reach from one side of the nation to the other. Informed sources say Hawaii is in the process of joining forces with the National Legislative Association on Prescription Drug Prices, which to date consists of all six New England states, New York, Pennsylvania and the District of Columbia.

January 16, 2003 | Daily News

CMS Administrator Tom Scully quietly hired a long-time AARP official last month, sparking speculation that the move could help the Bush administration's effort to enact a prescription drug benefit this year.

Marty Corry, who worked for AARP as its director of federal legislation, is now a special assistant to Scully. He will work on long-term care policies as well as other issues, according to an agency official. Several CMS stakeholders who attended recent CMS meetings said they were surprised to learn that Corry joined the agency in December.

January 15, 2003 | Daily News

CMS' implementation of national average wholesale price (AWP) rates for pharmaceuticals will yield modest savings, the bulk of which should come from generic drugs, according to an agency official.

January 15, 2003 | Daily News

The results of a new FDA survey of physicians' views on direct-to-consumer (DTC) advertising suggest consumers want to be informed about various drugs and that the agency's current DTC ad policy may be appropriate, an FDA source says. While the survey found doctors' viewpoints mixed, FDA was surprised at the percentage of doctors who viewed DTC ads as educational to patients, the source says.

[Click here for FDA's talk paper and the survey results.]

January 13, 2003 | Daily News

The incoming chair of the Senate Finance health subcommittee is calling on HHS to take action by Wednesday (Jan. 15) to help reinstate a Maine prescription drug assistance program struck down by a federal appeals court late last year.

Sen. Olympia Snowe (R-ME) is asking HHS to either implement one of three options proposed by Maine to resurrect its Healthy Maine Prescriptions program, or clarify for the court HHS' approval of the quashed program.

January 10, 2003 | Daily News

Sens. John McCain (R-AZ) and Charles Schumer (D-NY) have reintroduced legislation passed by the Senate last year that would reform drug patent law in an effort to speed generic drugs to market. On the same day, Jan. 7, the Democratic leadership included the same generic drug access proposal in broad-sweeping pharmaceutical legislation that would also establish a Medicare drug benefit and ease reimportation restrictions.

January 10, 2003 | Daily News

The European Union is trying to break a deadlock in World Trade Organization talks on providing access to generic copies of patented medicines by floating a compromise that uses the World Health Organization to determine the full scope of diseases covered by the new rules. But the United States has signaled that it does not see a need to go beyond the unilateral steps it has taken to address a limited set of grave infectious epidemics like HIV/AIDS after the WTO negotiations on the issue broke down late last year.

January 09, 2003 | Daily News

Rep. Thomas Allen (D-ME), an outspoken lawmaker on prescription drug pricing, is one of four new House Democrats appointed to the Energy and Commerce Committee. Reps. Janice Schakowsky (IL), Jim Davis (FL) and Hilda Solis (CA) are the other new Democrats on the panel.

January 08, 2003 | Daily News

The U.S. government will argue both for and against a Maine drug discount program scheduled for Supreme Court review this month. Having successfully petitioned the court to take part in the Jan. 22 hearing, the Office of the Solicitor General will present divided arguments on the Maine Rx plan, said a spokesperson for the federal government's top lawyer.

The drug industry has appealed to the high court over the state's drug law, which would require drug makers to pay Medicaid-priced rebates for drugs sold to all residents, not just those eligible for Medicaid.

January 07, 2003 | Daily News

Despite ongoing court action, CMS is moving ahead with its Medicare-endorsed prescription drug discount card program.

The agency intends publishing its official drug card sponsor solicitation soon in the Federal Register. Applications will be due March 7, according to a draft copy of the notice published last month.

CMS plans to announce those entities it has chosen to endorse in May, following which card sponsor enrollment will begin Sept. 30, the draft notice states.

January 07, 2003 | Daily News

Upcoming revisions to the tripartisan drug plan could include higher beneficiary cost-sharing to reflect current fiscal confines judging by recent comments from the top health aide to incoming Senate Finance Committee Chairman Chuck Grassley (R-IA).

Speaking at a Dec. 19 Alliance for Health Reform briefing, Finance Committee Republican health policy director Linda Fishman indicated that while the costs associated with providing a drug benefit have escalated, cost-sharing levels have remained static.

January 07, 2003 | Daily News

Senate Minority Leader Thomas Daschle (D-SD) Jan. 7 unveiled his party's legislative agenda for the 108th Congress, and swiftly introduced Democratic bills to provide Medicare prescription drug coverage, bolster homeland security and expand health care coverage. The Democrats' prescription drug bill would also reform drug patent law and allow reimportation of drugs from Canada -- two proposals passed by the Senate last year but never taken up by the House.

January 06, 2003 | Daily News

Brand-name drug company Organon says FDA should allow in the Orange Book method-of-use patents that claim unapproved uses of a company's already approved drug. The company maintains that the agency's stance that these patents cannot be listed is at odds with the goals of drug patent law.

January 06, 2003 | Daily News

Johnson & Johnson wants FDA to require generic drugmakers to provide innovators with samples of generic drugs so that brand-name companies can determine if the generic drugs infringe on their patents. J&J argues that such a requirement would reduce unnecessary patent infringement litigation, and that it is unfair that generic drug companies can sample brand-name products but brand-name companies cannot sample generic products.

January 06, 2003 | Daily News

The trade associations representing the generic and brand-name drug industries are clashing over FDA's plan to allow drug substance patents that do not claim the drug substance used in the approved drug (such as different crystal forms known as polymorphs) to be listed in the Orange Book. While the generic drug trade association says these patents should not be allowed in the Orange Book, the brand-name drug company says FDA already allows such listings and should acknowledge that it does.

January 03, 2003 | Daily News

In a surprise move, the generic drug industry trade group has decided to oppose a key element of the president's generic drug reform plan -- a proposal for a single 30-month stay per generic drug application. The Generic Pharmaceutical Association (GPhA) says the administration's 30-month stay proposal, which the White House touts as a move to increase generic drug access, could instead delay generic drug entry.

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