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Rx Drugs

April 19, 2004 | Daily News

Drug industry lawyers are considering asking lawmakers to set up a special drug injury compensation program that would offer no-fault compensation to those presumed injured by drugs while protecting pharmaceutical companies from liability. Industry lawyers say VICP, established in the 1980s to fix the problem of litigation over childhood vaccines, could be used as a model to compensate patients who suffer harm because of prescription drugs.

April 16, 2004 | Daily News

State prescription drug programs will be able to use their ability to supplement the new Medicare drug benefit to encourage competing drug plans to provide steeper drug discounts, more open drug formularies and less restrictive pharmacy networks, the head of one state plan told Inside CMS.

April 16, 2004 | Daily News

The Office of the U.S. Trade Representative has appointed Ralph Ives as an assistant USTR for pharmaceutical policy to address such issues as foreign drug price control systems and the reimportation of drugs, and has created a separate and expanded office of China affairs. Informed sources view the Ives' appointment as an effort by USTR to appease House Speaker Dennis Hastert (R-IL), who has criticized USTR for not tackling reimportation and price controls more aggressively.

April 16, 2004 | Daily News

The Senate health committee, which has jurisdiction over drug reimportation, has no plans to mark up reimportation legislation introduced last week by Finance Committee chair Charles Grassley (R-IA), a congressional source close to the issue says. Health committee chair Judd Gregg (R-NH) -- who disagrees with Grassley's use of the tax code to discourage companies from impeding imports and his plan to allow imports of unapproved drugs -- will introduce his own bill in a few weeks and hold a hearing, the source says.

April 15, 2004 | Daily News

The national association representing chain drug stores is pushing the Federal Trade Commission (FTC) officials to launch a broader investigation into the possible conflicts of interests of pharmacy benefit managers (PBMs) that operate mail-order pharmacies. The National Association of Chain Drug Stores (NACDS) says a newly launched FTC study -- mandated under last year's Medicare prescription drug act -- needs to look at a wide array of payments received by PBMs that boost the cost of drug coverage to health plans.

April 15, 2004 | Daily News

An orphan drug firm is urging FDA to resume a several-year-old press to eliminate the need for batch testing of U.S. drugs before they can be released in Canada and the European Union, this time through memoranda of understanding with the two countries. EU batch testing would have been eliminated under the U.S./EU pharmaceutical Mutual Recognition Agreement (MRA) signed in 1997, but the controversial agreement has yet to be implemented.

April 14, 2004 | Daily News

HHS is asking its drug importation task force to consider if the government should allow unapproved foreign drugs to be legally sold in this country, according to a new list of more specific and controversial questions HHS has asked the panel to tackle. However, panel members today (April 14) seemed skeptical of the idea and FDA reportedly is concerned about legislation that would allow for such imports.

April 14, 2004 | Daily News

Americans will no longer be able to use their MasterCard or Visa credit cards to buy drugs from some Canadian Internet pharmacies, Governor Jim Doyle (D) told HHS' importation task force April 14.

Spokespersons for Visa and MasterCard clarified that the companies recently sent Internet pharmacy guidelines to its member banks, and some of those banks may have decided to not do business with certain Internet pharmacies based on those guidelines.

April 13, 2004 | Daily News

A pharmaceutical supply company says prescription drugs could be safely imported into the United States through a closed system if distributors buy drugs directly from the manufacturer and transfer products between their own distribution centers in different countries. An FDA official says the agency had not heard of the idea before it was raised during an agency taskforce meeting last week, and will consider it.

However, the move may not result in cost savings for U.S. consumers, a representative for the company says.

April 13, 2004 | Daily News

The American Medical Association's (AMA) coding panel has set up a workgroup of physicians and CMS officials to prepare recommendations by this August for coding changes for administering drugs under part B, as oncologists have begun lobbying for changes that will increase reimbursement for chemotherapy and ancillary services.

April 13, 2004 | Daily News

Drug maker Novartis today announced it would supplement the low-income assistance under the Medicare discount drug cards, by offering drugs at no cost to beneficiaries who have spent their $600 annual credit. Novartis' effort follows on the heels of similar announcements by Merck and Eli Lilly.

April 13, 2004 | Daily News

CMS will exclude off-label uses of drugs and drugs that do not provide results as good or better than treatments currently covered by Medicare under a much-anticipated demonstration program the agency now says will be implemented this summer, well past the March 7 deadline set by the Medicare Modernization Act (MMA).

April 12, 2004 | Daily News

CMS is coming under pressure from biotech companies and their congressional allies over its continued failure to implement a provision of last year's Medicare law that allows hospital outpatient departments to receive maximum reimbursement for drug therapies as soon as they win FDA approval.

April 09, 2004 | Daily News

CMS is considering paying a supplying fee for pharmacies that provide immunosuppressant drugs for transplant patients after specialty pharmacies and their congressional supporters made the case that last year's Medicare law cut reimbursement rates below acquisition costs.

April 08, 2004 | Daily News

The pharmaceutical industry is weighing its legal options, following a federal appeals court's April 2 rejection of the industry's effort to kill a Michigan program that makes drug manufacturers offer additional rebates to avoid requirements that their drugs receive prior authorization before they are prescribed. The decision is a significant blow to the drug industry, as over 40 states have or are planning some type of prior authorization program to reduce drug prices.

April 07, 2004 | Daily News

Sen. Charles Grassley (R-IA), a key proponent of prescription drug importation in the Senate, introduced Thursday (April 8) a bill without support from Sen. Edward Kennedy (D-MA), with whom Grassley had been negotiating a bipartisan proposal. Talks between the two senators ceased because Senate Democratic Leader Tom Daschle (D-SD) asked Kennedy to stop working on a bipartisan bill, sources close to the issue say.

Kennedy and Daschle's spokespersons denied the charge, saying the two senators have always been keen on a bipartisan reimportation bill.

April 06, 2004 | Daily News

Sen. Norm Coleman (R-MN) plans to introduce legislation to curb illegal Internet sales of controlled substances, according to a congressional source. The bill by the chair of the Senate Permanent Select Committee on Investigations would be one of several introduced this session aimed at controlling scheduled drugs.

The legislation has not yet been written and will not be introduced for at least a couple weeks, the source says.

April 06, 2004 | Daily News

Several key brand-name drug companies -- including Abbott, Eli Lilly, Merck, Pfizer and Wyeth-Ayerst -- are facing pressure from shareholders to prepare a report either on how they will increase drug affordability and access or on ethical criteria for patent extensions. The companies expect certain shareholders to seek votes on these proposals at upcoming annual meetings of stockholders in April, and the companies are urging shareholders to defeat the proposals.

April 05, 2004 | Daily News

A little-known court decision involving disposable cameras may pose a major hurdle to mass importation of FDA-approved drugs from Canada. While the case had nothing to do with pharmaceuticals, the ruling touches on patent rights in parallel trading and appears to give an opening for U.S. drug companies to file patent infringement suits in certain cases against parties reimporting their drugs (see related story).

April 05, 2004 | Daily News

The Federal Trade Commission is urging a federal appeals court to overturn a lower court ruling that blocks Teva from marketing its generic Zoloft due to a settlement agreement between Zoloft producer Pfizer and the generic drug company Ivax. FTC says the district court decision, if allowed to stand, would allow a brand-name drug firm to collude with the first generic drug applicant to thwart generic drug competition.

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