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Rx Drugs

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.

March 05, 2002 | Daily News

A key Senate Democrat is rejecting AARP's proposal to use the Medicare Trust Fund to finance a comprehensive prescription drug benefit. The lawmaker's statements will likely end speculation on whether the trust funds will be touched to craft a drug benefit, since GOP House leaders also oppose the funding plan.

March 04, 2002 | Daily News

With the pharmaceutical industry already promising a fight, Sen. Byron Dorgan (D-ND), chair of a Senate Commerce and Transportation subcommittee, is planning to introduce a bill that would allow pharmacists and wholesalers to reimport drugs from Canada. The bill is likely to reignite controversy over reimportation, as the Pharmaceutical Research and Manufacturers of America (PhRMA) has promised to fight the impending bill, and an FDA source says the agency has safety concerns regarding the approach.

March 04, 2002 | Daily News

The state of Maine has won round one against a pharmaceutical industry bid to quash the state's prescription drug discount program for low-income residents.

In a Feb. 25 decision, the U.S. District Court for the District of Columbia has ruled in favor of the Healthy Maine Prescription Program (HMP), authorized by HHS to reduce prescription drug costs for needy residents ineligible for Medicaid.

March 04, 2002 | Daily News

Montana is taking several drug manufacturers to court over what the state believes is an abuse of the average wholesale price (AWP) system that it claims has cost Montana millions of dollars.

March 01, 2002 | Daily News

Top House lawmakers are reconsidering their stance on Medicare reform funding and may call for more resources to pay for prescription drug coverage, Medicare+Choice improvements, and provider payment adjustments, according to sources.

March 01, 2002 | Daily News

Pharmacy groups are "very likely" to resume their legal challenge over President Bush's prescription drug discount card following today's (March 1) release of the administration's revised initiative, according to an industry source.

Members of the two key pharmacy groups that successfully halted the administration's original card plan are meeting today to discuss continuing their court action. A source with one of the groups says the revised card plan is almost identical to the first proposal and therefore, violates the federal court injunction.