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Daily News

September 26, 2003

Senate health committee chair Judd Gregg (R-NH) is circulating a new version of his draft tobacco legislation that critics say would create legal loopholes favorable to tobacco companies. While the earlier draft reserved to Congress the power to ban tobacco, the new Sept. 17 draft further establishes that only Congress has the right to either "directly or indirectly" ban tobacco.

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A federal district court has given the brand-name drug industry and Maine four more weeks to work out a plan for how to proceed with the drug industry's legal case against Maine's landmark drug law, formerly known as Maine Rx. The U.S. Supreme Court returned the case back to the Maine federal court earlier this year after giving the state the go-ahead to finally implement the controversial law.

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Congress' investigative arm wants FDA to require drug firms conducting pediatric studies under the recently reauthorized pediatric exclusivity law to report each patient's race using a 2003 guidance's definitions, saying it is currently difficult to identify minorities in trials. The General Accounting Office Sept. 26 report also asks the agency to do a better job of tracking demographic information.

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Lawmakers and providers are urging CMS to adopt a suggestion from the Medicare Payment Advisory Commission (MedPAC) to relax the criteria used to classify hospitals as inpatient rehabilitation facilities (IRFs) pending further study.

The push marks the next stage in the ongoing dispute over so-called 75 percent rule which requires that three-fourths of a hospital's patients be diagnosed with one of 10 conditions in order for the facility to qualify for higher reimbursements as an IRF.

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September 25, 2003

President Bush has called House and Senate Medicare conferees to a White House meeting scheduled for 2:30 p.m. today (Sept.25), according to congressional sources. The scheduled meeting appears to fulfill calls from congressional leaders for a push by the president to bring contentious conference negotiations on the rival prescription drug bills to a successful conclusion.

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CMS Administrator Tom Scully says he has no immediate plans to leave his administration post, denying a published report that he would probably depart within a month, likely to the law firm Alston & Bird.

"I'm not going anywhere soon," he told Inside CMS. "I don't have any immediate plans. There are no negotiations, no job acceptances."

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Oncologists have mounted a new attempt to forge a compromise with Medicare conferees that averts drastic reimbursement cuts in both bills, putting forward an offer that signals a renewed willingness to accept a permanent fix to the average wholesale price (AWP) reimbursement system while demanding a three-year transition and over $1 billion in increased practice expense payments.

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Consumers find it difficult to retain and process drug side-effect information when it is placed in the middle of a direct-to-consumer advertisement, according to a Duke University study. These findings prompted FDA officials to discuss using cognitive principles to guide drug companies on the placement of risk information in DTC ads.

At FDA's Sept. 22-23 public meeting on DTC, Ruth Day from Duke University explained the effect of serial position on an individual's ability to retain information.

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FDA is working with the National Association of Boards of Pharmacy to craft an updated model practice act that states could use to develop state-of-the-art drug wholesaler licensing laws, according to an FDA official. The current model practice act for wholesale licensure is inadequate and more than a decade old, the official added.

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The Medicare conference will not reach an early agreement on provider issues, Ways and Means Committee Chairman Bill Thomas (R-CA) told Inside CMS after President Bush called the conferees to the White House today (Sept. 25) to urge them towards a successful conclusion to negotiations on a prescription drug bill.

"It's got too many facets to deal with in a finite way," Thomas said, noting that payments to insurers were in the mix of provider issues along with hospital and physician reimbursement. "That's part of the mix going forward."

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September 24, 2003

CMS is moving ahead with a back-up plan to ensure noncompliant providers keep getting paid by Medicare when new federal standards for electronic transactions go into effect next month. The move comes as some providers renew calls for further clarifications to the looming standard.

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Four months after it survived high court review, Maine's controversial law to cut prescription drug costs is slated to return to the courtroom Sept. 25 in a move that will determine the next step in the drug industry-initiated case. The court action comes just weeks after Hawaiian state lawmakers traveled to Maine to seek input on its copycat drug law, Hawaii Rx.

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A professional health and safety organization is calling on OSHA to create a separate reactive chemical standard that addresses potential chemical combinations that may cause reactive explosions in chemical facilities. Industry officials are essentially neutral on the group's recommendation while organized labor groups are advocating a different approach by calling on OSHA to, among other actions, add reactive chemicals to the agency's process safety management standard (PSM) to mitigate chemical explosions in the workplace.

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A generic drug industry official recommends that FDA support development of a new program to pool drug companies' data from audits of their active pharmaceutical ingredient (API) suppliers. A similar program already exists for software vendors, and the official suggests using the same approach to help reduce variation of quality of APIs.

Edmund Fry, vice president of compliance at Ivax Corporation, spoke on behalf of the Generic Pharmaceutical Association (GPhA) at the Sept. 17 meeting of FDA's Advisory Committee on Pharmaceutical Science manufacturing subcommittee.

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A generic drug industry official is calling for FDA to put an end to unnecessary testing requirements, including sterility testing, to improve drug quality.

Edmund Fry, vice president of compliance at Ivax Corporation, spoke on behalf of the Generic Pharmaceutical Association (GPhA) at the Sept. 17 meeting of the FDA Advisory Committee on Pharmaceutical Science manufacturing subcommittee.

Fry said experts have pointed to sterility testing for years as something that is not useful and costly. Sterility testing requirements are part of the current regulations.

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September 23, 2003

Under the Animal Drug User Fee Act (ADUFA) likely to be passed by Congress, company-initiated amendments to animal drug applications would "generally" restart the FDA review clock, an agency veterinary center official said. The official revealed that the agency also believes it can decide on a case-by-case basis if a CVM-initiated amendment is major and will thus impact the review timeframe, prompting industry concern.

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Senate Republicans and industry lobbyists are gearing up to fight a proposal being pushed by Sen. John Breaux (D-LA) as a replacement for pending legislation that would require most large, multi-plaintiff tort claims to be tried in federal courts, according to Senate and industry sources. Industry and Republican officials argue the new proposal would gut crucial provisions of the current "tort reform" bill by keeping most of these large lawsuits in state courts, which they say often impose unreasonably large damage awards on defendant companies.

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The Bush administration is tempering its concerns about using the precautionary principle (PP) when regulating environmental and other hazards in favor of requiring countries to justify its use based on a complex risk assessment framework, according to a draft White House position paper.

The draft paper says adequate environmental and health precautions are built into the U.S. regulatory system, which therefore does not warrant the additional measures some European Union member governments advocate.

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FDA's Anti-Counterfeiting Task Force is looking to standardize how it collects reports of suspect drugs and how the agency investigates those reports, according to an FDA source. FDA plans to issue the task force's interim report Thursday (Sept. 25).

Complaints about suspect drugs currently go to the agency's Office of Criminal Investigations, district offices or headquarters, according to Michael Rogers, one of the task force members. The agency would like the reports to come into just one office. Rogers did not specify what he meant by standardizing the investigative process.

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The House Ways and Means Committee's top Democrat today (Sept. 23) urged lawmakers to take steps outside of the bogged-down Medicare conference to lower drug costs, touting a bill to remove the corporate tax deduction for direct-to-consumer (DTC) advertisements that do not show the benefits and risks of medications in a "fairly balanced manner."

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