090404001 FDA's regulation of medical devices

FDA’s REGULATION OF MEDICAL DEVICES

“We
must not make a scarecrow of the law, setting it up to fear the birds
of prey, and let it keep one shape, till custom make it their perch
and not their terror.” William Shakespeare
(1564–1616), English poet and playwright.
(Microsft Corporation)

Congressional
investigators concluded in a report that most medical devices have
never been shown to be safe and tested and the procedure for doing so
must change for the devices which carry the highest of risks. Food
and Drug Administration (FDA) had promised for a long a time that
this problem would be fixed but apparently this has not happened,
which prompted Government Accountability Office to state in their
report that “it is imperative that F.D.A. take immediate steps”
to fix its system of approving devices. Various consumer agencies
have also complained that FDA was failing in protecting the public,
whereas, the industry groups also agreed that there were flaws in the
procedure per se. (Harris, Report Criticizes F.D.A. on
Device Testing)

Internal
FDA documents revealed that an FDA official went against FDA
scientists and approved the sale of an imaging device for breast
cancer when he received a phone call from a Connecticut congressman.
This phone call and its affect on the organization are recorded along
with many other accusations in important documents of this
science-based organization. FDA documents which are part of an
internal investigation were provided to The New York Times. These
documents indicate that the scientists within believe that the staff
has become too lenient in their standards of approving devices.
Scientists, within the organization, have criticized the process by
which many of the devices are approved without extensive testing.
(Harris, In F.D.A. Files, Claims of Rush to Approve Devices)

A
surgeon referred a patient of breast cancer, after surgery, for a
newer form of treatment where radioactive seeds are transplanted in
place where the tumor had been removed. It takes only five days as
compared to six weeks for conventional treatment. The system used to
administer this form of treatment is called MammoSite. This system is
among the many others which FDA allows for sale in market after a
quick test with no clear evidence if this might be helpful to
patients or not. FDA officials defend the cursory review process as a
way of promoting innovating technology. As newer products are simply
an improved over already approved products so they justify that there
is hardly a need for extensive tests as per procedure. Demanding
lengthy study of such devices would be “very, very
inappropriate and a waste of resources,” said Dr. Daniel G.
Schultz, the director of the F.D.A.’s Center for Devices and
Radiological Health. Even after six years of use, specialists are
still skeptical about the effectivity and benefits of MammoSite. Its
sale and use was allowed in the market only after a study that
involved 25 women who did not answer the fundamental questions about
its affectivity. (Abelson)

Medical
device manufacturers are not being scrutinized properly by FDA.
According to the Project on Government Oversight (POGO), the FDA's
Center for Devices and Radiological Health (CDRH) allows
manufacturers and testing facilities to monitor their own compliance
with federal regulations meant to insure the safety of medical
devices. (Alonso)

Critics
are of the opinion that devices should get the same scrutiny as drugs
do. While the process of scrutinizing drugs is not perfect but a new
drug is studied in hundreds or sometimes in thousands of patients
before it is approved as safe and effective by FDA. “Nobody is
looking to see whether they help patients, we’re never going to
wisely allocate resources in health care unless we start to focus on
what’s best for patients.” said Diane C. Robertson, an
executive with the ECRI Institute, which evaluates new devices for
insurers and hospitals. (Abelson)

A
report from POGO states that it seems that FDA decided to ignore the
Good Laboratories Practices (GLP) regulations. GLP is meant to
protect patients from unsafe drugs and devices by forbidding
manufacturers to set their own standards. This decision was made over
strong objection from FDA’s Center for Devices and Radiological
Health (CDRH) scientists. "There are many insiders who are
deeply concerned that real harm is being done. Such a decision
affecting public health should not have been made behind closed
doors." This is not the first time the FDA has
been criticized for its oversight of medical devices. In January
2009, the Government Accountability Office issued a report that
criticized the agency for failing to conduct appropriate medical
device reviews. In the same month, a group of FDA scientists wrote to
then President-elect Obama imploring him to reform the agency, which
they characterized as corrupt. The letter explained that that FDA's
regulation of medical devices was “corrupted and distorted by
current FDA managers, thereby placing the American people at risk.”
The letter also provided specifics about how scientists who differed
in opinion from FDA management were threatened with disciplinary
action. (Alonso)

Diana
Zuckerman, president of the National Research Center for Women and
Families, said the Bush administration had “finally made the
device approval process so meaningless that it’s intolerable to
the scientists who work there.” Ms. Zuckerman, a longtime
critic of the agency’s device approval process, particularly as
it relates to breast implants, added, “Virtually everything
gets approved, no matter what.” (Harris, In
F.D.A. Files, Claims of Rush to Approve Devices)

Why
have regulations which cannot be implemented to the letter and
spirit? Leaving out the spirit always results in a general disregard
for letter as well.

Works Cited

Abelson,
Reed. "Quickly Vetted, Treatment Is Offered to Patients."
The New York Times 26 October 2008.

Alonso,
Parker Waichman. "YourLawyer.com." 18 February 2009. Parker
Waichman Alonso LLP. 5 April 2009
<http://www.yourlawyer.com/articles/read/16085>.

Harris,
Gardiner. "In F.D.A. Files, Claims of Rush to Approve Devices."
The New York Times 12 January 2009.

—.
"Report Criticizes F.D.A. on Device Testing." The New
York Times 15 January 2009.

Microsft
Corporation. "Law." Encarta Book of Quotations.
1999. Bloomsbury Publishing Plc, 1999.