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Rx Drugs

August 05, 2004 | Daily News

The Medicare drug benefit implementation blueprint issued by CMS last week appears to give some low-income residents in a handful of states back-door access to federal help with their drug costs even if they officially fail to qualify for the financial aid.

August 05, 2004 | Daily News

CMS' proposed roadmap for Medicare's new prescription drug benefit suggests prescription drug plans may have to meet electronic prescribing standards as early as 2006 -- three years faster than originally specified.

CMS included language in its proposed drug rule, issued July 26, requiring plans to be able to support final CMS e-prescribing standards -- including those established before the drug benefit takes effect in 2006. CMS says it intends to mandate a "starter set of well-established standards" by the time drug coverage begins.

August 05, 2004 | Daily News

Sen. Orrin Hatch (R-UT) is contemplating whether to back a proposal to provide drug makers with incentives as part of "BioShield II" legislation to develop new antibiotics, according to a source close to Hatch. Hatch is the cosponsor of S. 666, known as BioShield II by lobbyists who pushed for the original BioShield Act. Sen. Joseph Lieberman (D-CT), the primary force behind S. 666, plans to introduce legislation after the congressional recess that includes incentives for developing antibiotics.

August 04, 2004 | Daily News

Pharmacy Plus drug coverage programs will not be allowed to fill in the gap in coverage in the part D prescription drug benefit and the four states currently running them should therefore direct their Pharmacy Plus spending toward state pharmaceutical assistance programs (SPAPs) which can do so, CMS says in its newly proposed rule for the January 2006 drug benefit.

August 04, 2004 | Daily News

The Pharmaceutical Research and Manufacturers of America (PhRMA) is calling for several technical clarifications to FDA's guidance on fixed-dose combination (FDC) and copackaged HIV drugs, including a call for the agency to clarify when separate package inserts would be allowed for copackaged drugs.

August 04, 2004 | Daily News

A coalition that includes large corporations such as General Motors, Caterpillar and Kodak is maneuvering to throw its support behind a push for generic biologics, according to generic drug industry sources. Many of the companies in the Coalition for a Competitive Pharmaceutical Market were also involved in the push to change drug patent law that further opened the market to generic drugs.

August 04, 2004 | Daily News

The National Institutes of Health has rejected requests from lawmakers and the public that the government allow generic competitors to Abbot Laboratories' AIDS drug Norvir -- signaling that high drug prices alone are not enough for NIH to take such extraordinary action without additional guidance from Congress. The move, unveiled Wednesday (Aug.

August 04, 2004 | Daily News

CMS actuaries have added $30 billion to their five-year projected cost for private Medicare plans and hiked estimates of per-capital drug expenditures by $11 billion as part of revised estimates included in the mid-session budget review released by the Office of Management and Budget (OMB) this week.

August 04, 2004 | Daily News

Consumer advocacy group Public Citizen is asking FDA to launch a criminal investigation into an alleged delay by drug maker AstraZeneca in disclosing adverse effects data about the company's cholesterol-lowering drug Crestor, which the group has repeatedly petitioned FDA to pull from the market. Public Citizen charges that AstraZeneca withheld from FDA information about negative reactions to Crestor well beyond the legal deadline and is reiterating its call to have the drug disapproved for sale, confident that a criminal probe will provide the agency with more incentive to do so.

August 03, 2004 | Daily News

Sen. Orrin Hatch (R-UT) may take issue with a Congressional Research Service suggestion that patent reforms included in drug reimportation legislation could be narrowly crafted to cover only pharmaceuticals, a source close to the Judiciary Committee chair says. Hatch may argue that any changes to international patent exhaustion terms must apply to all products -- a view that could snag efforts by Sen. Byron Dorgan (D-ND) to push legislation aimed at stopping drug firms from using patent law to block reimportation.

August 03, 2004 | Daily News

AARP, the Medicare Rights Center (MRC), the National Committee to Preserve Social Security and Medicare (NCPSSM) and other groups are mounting localized campaigns to urge their members to press lawmakers to pass by the end of the year a bipartisan Senate bill that would allow drug reimportation.

August 02, 2004 | Daily News

An HHS advisory panel is preparing to recommend that the agency adopt a uniform definition of minimal risk for research involving children, and clarify the definition of minimal risk applied to research conducted on inmate populations. The proposals, which are in draft form, call for new language to be added to the federal regulation that defines human subject protection and new standards for institutional review boards.

August 02, 2004 | Daily News

In an effort to maximize the number of employers that retain retiree drug coverage and opt to receive a tax-free subsidy for drug costs, CMS is considering a series of options that give employers greater ability to shift premium costs onto retirees.

August 02, 2004 | Daily News

An HHS advisory panel is leaning toward endorsing a proposal to set up a clinical trial database for research conducted on prisoners, a plan that would be carried out following a revision of the federal regulation that oversees prison clinical research. Although the report does not mention an inmate registry, the subject was brought up briefly during panel discussion, and a source close to the issue calls the idea an "implied suggestion."

August 02, 2004 | Daily News

The process to develop model guidelines for the new Medicare drug benefit is coming under fire for a lack of transparency from a range of stakeholders, including those handpicked to serve on advisory forums, despite recent efforts by U.S. Pharmacopeia (USP) to make public the process it has conducted behind closed doors since early May. USP officials defend the process, pointing to an upcoming opportunity for public comment after the draft guidelines are released next month.

July 30, 2004 | Daily News

FDA has issued a guidance defining "available therapy" and "existing treatment" -- terms appearing in many agency regulations and policy statements which have caused confusion in industry -- as generally covering only FDA-approved treatments. The guidance is important because many of the methods FDA uses to speed products to market require that there not already be an available therapy for the disease or condition that the new product is purporting to treat.

July 30, 2004 | Daily News

FDA is setting up a Pediatric Advisory Committee in the commissioner's office that will advise the agency on pediatric therapeutics and research, and is launching a subcommittee to look at pediatric research ethics issues. The Best Pharmaceuticals for Children Act mandates the creation of the advisory committee.

FDA is currently requesting nominations for members to serve on the new advisory committee. Members will include pediatric research scientists and consumer, industry and pediatric representatives, according to an agency notice.

July 30, 2004 | Daily News

A major Florida homecare company is threatening to drop its Medicare lung disease patients on the eve of the presidential election, after CMS issued a proposed rule slashing payments for inhalation drugs and indicating any compensatory fee would be limited and of short duration.

Lincare Holdings Inc. said its decision to continue to serve patients with chronic obstructive pulmonary disease hinges on the adequacy of the dispensing fee CMS sets to make up for cuts of about 90 percent in the reimbursement for drugs dispensed through nebulizers.

July 29, 2004 | Daily News

FDA is asking Wisconsin Gov. Jim Doyle (R) to shut down a state Web site directing citizens to cheaper Canadian prescription drugs because Canadian pharmacies listed on this site are violating sale agreements with the state, the agency says. FDA says that despite warning letters from state agencies, Canadian pharmacies are selling drugs with no FDA-approved version in the United States, and some drugs are not even listed on the Wisconsin Web site.

July 29, 2004 | Daily News

A law firm representing the cosmetics industry is pushing FDA to drop plans to classify over-the-counter (OTC) nasal moisturizers as drugs under an OTC monograph. The law firm of Kirkpatrick & Lockhart, in June 28 comments to FDA, asserts that OTC nasal treatments clearly fall into the cosmetics category as outlined by the Food, Drug, and Cosmetic Act (FDCA). FDA issued a request for data to set up a new monograph for nasal products in December 2003.

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