An orphan drug firm has submitted a petition asking FDA's drug center to stop requiring user fee payments while a waiver request is pending. The firm charges that the agency's current policy of requiring firms to pay user-fees before FDA decides if a waiver should be granted is unlawful. The company also asks the agency to transfer responsibility for the user-fee program from the drug center back to the commissioner's office.
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Daily News
February 11, 2003
A federal appeals court says FDA lacks the authority to regulate the packaging of solid dosage dietary supplements and drugs to prevent poisoning caused by misuse of products. The appeals court, reversing a district court decision, took issue with a 1997 FDA regulation that requires manufacturers of iron-containing drugs and supplements to use unit-dose-packaging.
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A top HHS official is seriously considering leaving his post to enter the race to become the next governor of Louisiana, according to sources. Bobby Jindal, HHS assistant secretary for planning and evaluation, will soon decide whether he will launch the gubernatorial bid, the sources add.
Louisiana Gov. Murphy "Mike" Foster (R), who is in his last term, has publicly urged Jindal to run for his office and sources say the HHS official is very close to making a decision. Foster's term expires this year.
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FDA has ended a 1999 pilot program under which device manufacturers were given a chance to quickly correct quality system (QS), labeling and 510(k) violations or deficiencies in order to avoid receiving a warning letter. FDA says the pilot did not provide industry an incentive to promptly correct violations and the Office of Chief Counsel's new warning letter review addresses some of the concerns raised by industry, according to an FDA Federal Register notice.
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February 10, 2003
Getting Congress to pass President Bush's Project BioShield proposal will be difficult in large part because it would give the president the authority to spend money on biodefense products without congressional approval, according to a top HHS official. Legislation would also be required to implement the new FDA approval process proposed by the president for speeding biodefense products to market.
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A group of House Republicans led by House Speaker Dennis Hastert (R-IL) and Majority Whip Roy Blunt (R-MO) are urging President Bush to launch a challenge against the European Union's biotechnology moratorium in the World Trade Organization. Cabinet-level officials of the Bush administration were set to decide last week whether to bring a case against the EU, but the meeting was postponed indefinitely.
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Attempts by both the European Union and Japan to find a compromise to deadlocked World Trade Organization (WTO) talks on more flexible drug patent rules fell flat last week, as African countries rejected any limitations on the scope of diseases and the United States made no movement toward agreeing to a broader scope for an agreement.
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Washington's OSHA and AFL-CIO are asking the state's Supreme Court to uphold the decision of a lower court that rejected an industry challenge to Washington's ergonomics standard.
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FDA's device center has already written the guidance documents necessary to start collecting device user fees, but cannot release them until Congress passes FDA's fiscal year 2003 appropriations bill, according to a source following the process.
FDA also has opened a docket where stakeholders can submit comments on the new device user fee law. The agency is urging industry to comment on key aspects of the fee collection system, as well as comment on how the agency should collect safety information on pediatric devices.
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The chairman of the WTO Council on Trade Related Aspects of Intellectual Property Rights Feb. 10 asked the World Trade Organization General Council for another week to see if the United States and other key players will sign on to an agreement giving countries the right to source production of generic drugs abroad now that he has proposed a compromise designed to limit use of these rights to dealing with national emergencies.
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February 07, 2003
The latest proposal from some of the industry groups involved in the initiative to update OSHA's outdated permissible exposure limits (PELs) is stalling the progress of the working group, according to sources.
Late last year, stakeholders had predicted that the PEL working group, which is seeking to build a consensus on how to update the exposure limits, would fall apart, and a new industry proposal that one source called a "step backward" confirms that the effort has stalled.
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A key homecare group is blasting a federal advisory panel's new recommendations on Medicare home health payments, claiming they "completely contradict" the committee's stance of just one year ago.
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FDA regional offices and the states would get the lion's share of a whopping $20.5 million increase requested by President Bush to protect the food supply against deliberate contamination in fiscal year 2004. If approved by Congress, field offices would get $17 million more for food safety than requested by Bush for FY 03, with the remaining $3.5 million increase going to the food center, according to an FDA budget brief.
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Patient safety, a big priority of FDA Commissioner Mark McClellan, would receive a $7 million increase over last year's request in President Bush's fiscal year 2004 budget -- $3 million of which would come from the office generic drugs' budget. McClellan asked to take the extra money out of the office generic drug's budget because he saw it as a way of getting more money for patient safety, according to Jeff Weber, FDA's senior associate commissioner for management and systems.
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Relying on a rarely used policy, FDA is offering safety and efficacy data to get companies to quickly submit marketing applications for Prussian blue, a treatment for exposure to dirty bombs. FDA has even prepared draft labeling for the product and new drug approval (NDA) applicants will only be required to submit chemistry information for their product.
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Medical device industry trade groups are scrambling to come up with a plan to convince congressional appropriators to hike the FDA device center's budget in a bid to keep the newly enacted device user fee program afloat. Representatives from the Advanced Medical Technology Association (AdvaMed) and the Medical Device Manufacturers Association (MDMA) were already meeting two days after the release of the administration's fiscal year 2004 budget proposal -- which falls considerably short of the average annual funding needed to keep the user fee program going.
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Two powerful GOP lawmakers who have radically different proposals on how to avert a looming Medicare physician payment cut will discuss the controversial issue this weekend at a high-profile Republican retreat in West Virginia, sources say. If the two lawmakers from opposite sides of Capitol Hill are unable to resolve their differences in the next week, the scheduled 4.4 percent physician payment cut will go into effect on March 1, health care experts say.
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February 06, 2003
The Bush administration is working with lawmakers on legislation that would set up a compensation program for those injured by voluntarily taking the smallpox vaccine, and legislation likely will be unveiled in the coming weeks, according to a top Centers for Disease Control and Prevention (CDC) official.
Several state officials stressed the need to address compensation during a National Governors Association bioterrorism summit in Washington, DC this week, arguing that lack of adequate compensation and concerns about liability will likely keep hospitals from participating.
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Although the Bush administration launched the initial stage of its smallpox vaccination program on Jan. 24, only 11 states and one city have begun administering the vaccine to eligible healthcare workers and front-line responders to terrorist events, and less than 1,000 people have been vaccinated, according to an administration official. Others have announced their plans to wait until the middle or end of February, and there are some outlying areas that will not begin smallpox vaccinations for the initial group at least four months.
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The Bush administration plans to allow members of the general public to be inoculated with the smallpox vaccine by mid-to-late summer, but is still struggling with which version of the vaccine to make available and who would administer it, according to a top official from the Centers for Disease Control and Prevention (CDC).
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