considered lean and efficient by the drug industry. Furthermore, unlike the FDA, the EMA maintains a close
liaison with medical professionals and draws willingly
from their clinical expertise. 23
There is no shortage of inventive proposals for correcting the problems that plague the FDA, many of
them coming from the agency’s previous leadership. 24
For example, former FDA Commissioner Andrew von
Eschenbach, MD, makes a strong case for accelerated
drug approvals based on safety trials alone, reserving
efficacy determination for post-market monitoring of
the same test subjects. 25 For devices, Henry I. Miller
MD, MSc, founding Director of the FDA Office of Biotechnology, urges adoption of the nationally recognized
and proven testing laboratory model, best exemplified
by the highly successful Underwriters Laboratory, Inc. 26
But these revisions cannot become reality without congressional action. Consider, for example, a bill
now under debate, the Promise for Antibiotics and
Therapeutics for Health (PATH) Act. With bipartisan
sponsorship, it provides for accelerated approval of new
antibiotics for an emerging class of resistant organisms.
Any endeavor that promises new antibiotics is a noble
cause but there are outspoken critics of the measure.
Readers of this article are now primed to monitor the
bill’s progress and learn who supports and who opposes
the legislation. 27
Meanwhile, surgical specialty organizations are free
to maintain their preferred relationship with regulators.
The American Academy of Orthopaedic Surgeons represents a model for sustaining a productive liaison with
the FDA, and plastic surgeons have learned to pursue
a more proactive stance with the agency. Expanding
on the advisory panel format, the American Society of
Plastic Surgeons and its foundation, The Plastic Surgery
Foundation, remain vigilant regarding problems involving the use of devices. These entities seek advice from
their own advisory panels and, on their own initiative,
forward relevant information to the FDA.
One such problem is the risk that never seems to go
away—cancer following breast implantation. Beginning
in 1998, reports of a lymphoma developing in the fibrous
14. Nocera J. Fatal Litigation. Fortune. October 16, 1995, 137-
15. Cimons M. Silicone implant maker proposes study: Human
trials to answer safety questions could forestall ban on the
device. Los Angeles Times. February 20, 1992. Available at:
silicone-implant. Accessed October 16, 2015.
16. Statement of ACS Regent Maurice J. Jurkiewicz before FDA
Advisory Panel for General and Plastic Surgery Devices,
November 12, 1991.
17. Institute of Medicine (US); Grigg M, Bondurant S, Ernster
VL, Herdman R, editors. Information for Women About the
Safety of Silicone Breast Implants. Washington , DC: National
Academies Press; 2000.
18. Nocera J. Dow Corning succumbs. Fortune. October 30,
19. Miller HI. Sick Process. Hoover Digest. 1999. Available at:
www.hoover.org/research/sick-process. Accessed October
20. Bernstein DE. Review: The breast implant fiasco. California
Law Rev. 1999; 87( 2):457-510.
21. Medical Device Amendments of 1976. 94th Congress.
May 28, 1976. Available at: www.gpo.gov/fdsys/pkg/
STATU TE-90/pdf/S TATU TE-90-Pg539.pdf. Accessed
October 16, 2015.
22. U.S. Food and Drug Administration. 2006
Device Approvals. Available at: www.fda.gov/
DeviceApprovalsandClearances/Recently-ApprovedDevices/ ucm073317.htm. Accessed October 23,
23. Perkins LL, Clark BD, Klein PJ, Cook RR. A meta-analysis
of breast implants and connective tissue disease. Ann Plast
Surg. 1995; 35( 6):561-570.
24. Fisher JC. Silicone on Trial: Breast Implants and the Politics of
Risk. New York, N Y: The Sager Group; 2015.
25. von Eschenbach A. Medical innovation: How the U.S.
can retain its lead. Wall Street Journal. February 14, 2012.
Available at: www.wsj.com/articles/SB100014240529702036
46004577215403399350874. Accessed October 16, 2015.
There is no shortage of inventive proposals for correcting
the problems that plague the FDA, many of them coming
from the agency’s previous leadership.... But these revisions
cannot become reality without congressional action.
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