FDA & Digital Mammography

Digital mammography is routinely used in the US to screen asymptomatic women for breast cancer and currently over 50% of US screening centers employ the technology. In spite of FDAs knowledge that digital mammography requires less radiation than film mammography and that its equivalence has been proven in a prospective randomized trial, the agency has failed to allow the technology market access via the 510(k) pre market clearance pathway. As a result of the restrictive Pre Market Approval process, only four suppliers have received FDA approval. The resulting lack of a competitive market has kept costs high, restricted technological innovation, and impeded product improvements as a result of PMA requirements. Meanwhile, at least twelve companies are on the market in the EU and the resulting competitive market has lowered costs and provided increased technological choice.

A cultural change with new leadership occurred in the early 90’s at FDA. The historical culture at the Center for Devices and Radiological Health of collaboration and education gave way to one characterized by a lack of reliance on outside scientific expertise, tolerance of decision making by unqualified reviewers, and an emphasis on enforcement and punishment. Digital mammography fell victim to this cultural change and as a result major innovations like breast CT and computer aided detection technologies are also withheld from the market.

The medical device law, currently under review by the Institute of Medicine, should be amended by the Congress so that new technologies can be appropriately classified in accordance with the risk based assessment classification system detailed in Chapter V of the Federal Food, Drug, and Cosmetic Act. A panel of scientific experts chartered by the NIH or IOM should determine the classification appropriate for new technologies that have no historical regulatory framework. This would be binding on FDA. Unless the law is changed we will likely again experience additional debacles similar to that of digital mammography where important technology has been withheld from millions of women for more than a decade.

Medical devices substantially equivalent to existing devices are approved for sale in the United States by the US Food and Drug Administration (FDA) under a straightforward 90-day process called 510(k) or a complex multiyear premarket approval (PMA) process requiring expensive clinical trials.

After 15 years of studying full-field digital mammography (FFDM), 10 years after the first system was approved under a PMA, and after more than 50% of the US market uses FFDM for screening, the FDA still has not allowed a 510(k) clearance pathway for digital mammography, the only imaging modality that requires a PMA to gain market access.

On November 17, 2009, the FDA convened the fourth meeting of the Radiological Devices Panel of its Medical Devices Advisory Committee to discuss regulatory guidance for full-field digital mammography systems. Four years after the publication of the National Cancer Institute funded Digital Mammography Imaging Screening Trial (DMIST), which demonstrated equivalence between FFDM and film mammography , the FDA continues to be unable to reclassify FFDM to a 510(k) from a PMA. As a result of this ongoing bureaucratic logjam, there are only four manufacturers selling full-field digital mammography systems in the United States (from GE, Siemens, Hologic, and Fuji), whereas more than 12 systems are on the market in Europe (from Carestream Health, Philips, IMS Giotto, Planmed, GE, Siemens, Konica, Agfa, Fuji, Sectra, and Metaltronica).

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To tell you the truth, I don’t know where this list came from. Can you clarify that for me? Where did these additional stresses come from? Where did you find these out from?…I don’t know…what they’re trying to get at with these various scenarios.…I don’t know what that has to do with anything.

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Regulatory background

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Table 1

User Fees Paid to the FDA for Medical Device Approvals in 2010 and the Number of Submissions the FDA Received in 2008 for the Most Frequent Regulatory Categories

2010 User Fees 2008 Submissions PMA applications $217,787 31 180-day PMA supplements $32,668 253 510(k) $4007 3902

FDA, US Food and Drug Administration; PMA, premarket approval.

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Mammography systems

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From their enactment in 1976 until the early 1990s, the Medical Device Amendments’ implementation was quite faithful both to the specific language and to the spirit and intent of the legislation. In the past five years, this has changed dramatically. What FDA is doing in many areas today is both outside the statute’s specific language and contrary to Congress’s original intent in enacting the statute.

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Apparently, a new sheriff was in town

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“The FDA is in the worst state of disarray in four decades.…The agency now needs a real leader who will focus on the agency and not on their own personal agenda,”…said former FDA general counsel Peter Barton Hutt. Hutt and other critics characterized [the commissioner] as an overzealous regulator who put publicity-grabbing initiatives before issues of public health.

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It’s clear that there is a gap between the scientific expertise needed and the competencies of the current staff.…We characterized CDRH as an organization…[in which] there is no effective interoffice communication and coordination. Furthermore, external experts are seldom used beyond those who sit on existing FDA advisory panels.…As part of this, CDRH should expand its outreach to and scientific interactions with both industry and universities.

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[Our view] is very concordant with one of your recommendations, scientific partnerships with the [National Institutes of Health], the National Academy of Science, universities, professional societies. Many of these exist, but they are under-developed. We could do much more with them than we currently do.

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The digital mammography imaging screening trial

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Amendments to medical device law are needed

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The scientific reviewers presenting today will provide their views on the topic, and you may find they differ in some aspects. It should be noted that the viewpoints expressed today do not necessarily represent a consensus opinion within the FDA or align with existing Agency policy.

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References

1. Pisano E., Gatsonis C., Hendrick E., et. al.: Diagnostic performance of digital versus film mammography for breast-cancer screening. N Engl J Med 2005; 353: pp. 1773-1783.
2. US Food and Drug Administration, Center for Devices and Radiological Health, Medical Devices Advisory Committee, Radiological Devices Panel. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/RadiologicalDevicesPanel/UCM197418.pdf . Accessed February 9, 2010.
3. US Food and Drug Administration. FY 2008 performance report to the president and the Congress for the Prescription Drug User Fee Act. Silver Spring, MD: US Food and Drug Administration.
4. US Food and Drug Administration. Premarket notification (510k). Available at: http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/default.htm . Accessed February 9, 2010.
5. Tran V. The Radiation Control for Health and Safety Act of 1968: history, accomplishments, and future. Available at: http://leda.law.harvard.edu/leda/data/792/Tran06.pdf . Accessed February 9, 2010.
6. Urban M.A.: The FDA’s policy on seizures, injunctions, civil fines, and recalls. Food Drug Law J 1992; 47: pp. 411-412.
7. The development of the Medical Device Amendments: an interview with Peter Barton Hutt. Medical Device & Diagnostic Industry Magazine May 1996;
8. Schwartz J.F.D.A.: commissioner Kessler will resign early next year. The Washington Post November 26, 1996;
9. Pisano E.D.: Current status of full-field digital mammography. Radiology 2000; 214: pp. 26-28.
10. US Food and Drug Administration. Charter of the Science Board to the Food and Drug Administration. Available at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ScienceBoardtotheFoodandDrugAdministration/ucm115356.htm . Accessed February 9, 2010.
11. US Food and Drug Administration. Science Board meeting. Available at: http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3799t1.htm . Accessed February 9, 2010.
12. US Food and Drug Administration. Premarket applications for digital mammography systems; final guidance for industry and FDA. Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073624.htm . Accessed February 9, 2010.
13. US Food and Drug Administration. Draft guidance for industry and FDA staff: class II special controls guidance document: full field digital mammography system. Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm107552.htm . Accessed February 9, 2010.
14. US Food and Drug Administration. FY 2010 all purpose table—budget authority. Available at: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM153876.pdf . Accessed February 9, 2010.
15. Institute of Medicine. Public health effectiveness of the FDA 510(k) clearance process. Available at: http://www.iom.edu/Activities/PublicHealth/510KProcess.aspx . Accessed February 9, 2010.
16. Harris G. In F.D.A. files, claims of rush to approve devices. The New York Times. January 12, 2009.

FDA & Digital Mammography

Regulatory background

Mammography systems

Apparently, a new sheriff was in town

The digital mammography imaging screening trial

Amendments to medical device law are needed

References

Further Reading

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