AdvaMed fights to keep user fees out of sequester cuts for FDA

AdvaMed logo

The medical device industry doesn’t want user fees paid by industry to be included in a series of cuts slated for the FDA’s budget this week.

The federal watchdog agency will have $210 million, or about 5.1% of its $4.1 billion budget, cut from its 2013 budget March 1 as a result of sequestration, the bargain between the White House and Congress.

Included in those cuts are the user fees medical device and pharmaceutical companies pay in order to insure timely reviews of new drugs and devices.

AdvaMed, the industry’s lobbying voice in Washington, D.C., said today that it’s prepared to stand "shoulder to shoulder" with the agency to protect the agency from those cuts.

"The fees voluntarily paid by industry in exchange for meeting certain performance goals are not tax payer dollars and should not be considered in the same light as appropriation funding," Zimmer (NYSE:ZMH) CEO and AdvaMed board chairman David Dvorak said during a conference call. "The FDA should have full access to fees paid by industry and the agency should be properly funded to meet its obligations under the new user fee agreement."

The medical device industry is prepared too "stand together, shoulder-to-shoulder with the FDA regarding negative impacts of sequestration and continuing resolution on the device center’s operations. Everyone knows how much effort we’ve put in towards improving performance in the device center and highlighting the role the agency plays in maintaining our global leadership," added AdvaMed president Steven Ubl. "Simply put, I think we’ve come too far to see these gains unraveled due to ill-considered approaches [to federal spending]."

Should the March 1 sequestration deadline pass, the fiscal 2013 impact will amount to an across-the-board cut of between 5.1% and 5.3% to the FDA’s appropriated budget, which includes the user fees, according to AdvaMed.

Unless Congress acts to change the rules of the sequester, those cuts will be applied across the board to all programs run by the FDA, according to the Alliance for a Stronger FDA. User fees are included in the cuts because of a decision by the Office of Management & Budget, last September, according to the Alliance.

Using a back-of-the-envelope calculation, J.C. Scott, AdvaMed’s senior executive vice president of government affairs, told MassDevice.com that sequestration could result in roughly $20 million being slashed from the budget of the Center for Devices & Radiological Health, including about $3 million worth of user fees paid by industry.

Those cuts are exacerbated by the fact that the agency is operating at its 2012 funding level, under the terms of a continuing resolution passed last summer by lawmakers to fund the federal government. The current federal budget continuing resolution, unless corrected, also limits FDA’s ability to access user fees, AdvaMed said.

RSS From Medical Design & Outsourcing

  • Drug Deactivation program roll out to all facilities for safe disposal of unused prescription medications
    Verde Technologies announced that New Brighton-based Meridian Behavioral Health, the largest for-profit substance abuse and addiction treatment group in Minnesota, has become its most recent partner in the deactivation and safe disposal of prescription medications including methadone. Meridian is the first behavioral health group to roll out the Deterra Drug Deactivation System to all 17 […]
  • Lophius Biosciences introduces T-activated ImmunoScan Cocktail
    Lophius Biosciences announced the commercial launch of T-Track ImmunoScan and T-activated ImmunoScan Cocktail. Based on a proprietary and very specific cocktail of stimulants in combination with the Company’s T-activation technology, T-Track ImmunoScan and T-activated ImmunoScan Cocktail specifically target different cell types involved in both the adaptive and innate immune system. T-Track ImmunoScan and the T-activated […]
  • Cosasco’s wireless communications protocol makes electrically hazardous areas safer
    Cosasco has expanded the functionality of its CWT-9020 wireless water system corrosion monitor for electrically hazardous areas by offering ISA100 Wireless communications protocol. Along with WirelessHART 7, the new protocol option allows the transmitter to integrate with an even wider range of existing wireless systems. ISA100 Wireless supports more wireless devices and provides an effective […]
  • Vicon captures a new development in motion capture (mocap)
    Vicon announced the launch of its new flagship camera platform, the Vicon Vantage. Drawing on over 30 years’ of motion capture (mocap) experience, the Vantage platform combines innovative technology with accessible design to open up motion capture to a broader audience. Vicon is a motion capture technology specialist company for science and life industries. Advances in […]
  • Satel’s latest product sets a new milestone in radio manufacturing
    The new Satelline TR4, from the Finnish manufacturer of radio data transmission systems, Satel sets a new milestone. The compact UHF transceiver with transmitting power of 1,000 mW is compatible with the protocols of Pacific Crest, Trimble and Satel. The type certifications in all important regions of the world make the TR4 ideal for integration […]
  • SCHURTER announces retirement of founder and management changes
    SCHURTER announced the retirement of founder Bruno H. Schurter on June 29, 2015. The company, founded in 1982 in Petaluma, California, will change management effective July 1, 2015. Bruno H. Schurter, president and CEO will retire after 33 years of heading up the privately held company, which is a subsidiary of SCHURTER Holding AG, founded in […]
  • Silicone: Expanding the horizon for modern medical devices
    Editor’s note: This article comes from Albright Technologies a manufacturer of custom silicone prototypes and provides volume production for medical, pharmaceutical, industrial, and other applications. Silicone materials have been around for more than 70 years. Beginning in the 1960s, silicones have played an important and evolving part in products designed for the medical field. Since that time, […]
  • DeNovo Sciences appoints a molecular diagnostics veteran as new CSO
    DeNovo Sciences, a producer of  liquid biopsy products, announced the appointment of Dr. Yixin Wang as Chief Scientific Officer (CSO). Dr. Wang is a veteran in molecular diagnostics where he has played significant R&D roles at large, multi-national companies including Parke-Davis/Pfizer, Veridex/Johnson & Johnson and Ventana/Roche. He will lead strategic initiatives for clinical development of DeNovo’s […]
  • Albright Technologies expands their silicone offerings
    Albright Technologies, a rapid silicone prototyper, has added silicone injection molding tooling and services to its product lineup. Liquid silicone injection molding became a suitable product offering as Albright expanded its offerings to better serve the silicone molding market. While silicone prototypes are commonly manufactured with low volumes in mind; injection molded liquid silicone rubber parts are […]
  • Applied Silver launches SilvaClean, silver treatment for textiles
    Applied Silver, Inc, is launching SilvaClean, a state-of-the-art silver treatment for textiles, at the Association for Professionals in Infection Control and Epidemiology’s (APIC) forty-second Annual Conference taking place at the Music City Center in Nashville, from June 27 through June 29. Hospitals have invested significantly in reducing the potential of infection through products and processes designed […]
  • Two-Component technology for improved quality of life
    In the field of injection molding and mold making, toolcraft covers all processes within the added value chain–from the design and selection of materials through to the creation of finished and qualified products. Complete solutions offered include injection molding for parts in the small and extremely small component areas, e.g. for medical technology. Utilizing two-component […]

Leave a Reply