Dr. Feigal replaces Bruce Burlington, M.D., who left FDA in mid-March.
Since 1993, under Dr. Burlington's leadership, FDA's devices center eliminated its
product review backlog and cut review times in half. Dr. Feigal will begin assuming his
new duties immediately, and he is expected to be working full time on devices after a
transition period of approximately one month.
The Center is responsible for ensuring the safety and effectiveness of all
medical devices, including heart valves, joint
replacements, and a broad range of medical, surgical and hospital equipment. The Center
also ensures the safety of consumer and medical radiation-emitting equipment such as
x-ray machines, microwave ovens, mammography equipment and television sets.
Device Approval Tightens
Dr. Feigel's medical and drug background is likely to move CDRH closer
to the kind of safety and efficacy standards heretofore reserved for
pharmaceutical products. This will be especially
difficult for companies outside the U.S., for whom standards have generally focused on
safety criteria similar to those certified in the U.S. by Underwriters Laboratory.
FDA's more stringent requirements for product performance and efficacy has caught
more than one company unaware of the difference in FDA's approach to device
marketing approvals. The mutual recognition agreement between the U.S. and E.U.
relates to product quality systems and may be only marginally helpful since
inspections of facilities in the E.U. will be to U.S. quality standards even if carried
out by local E.U. national inspectors. And of course, many non-U.S. device
manufacturers must still overcome the NIH factor, "Not Invented Here", which
appears to affect all regulatory agencies,
including FDA. For that reason, it is important to provide not only sound study
reports and data, but also to provide the information in the format and language
familiar to FDA reviewers and staff.
FDA Requires Premarket Approvals for Some Diathermy and Muscle Stimulator Devices
Speaking of devices, FDA recently issued a notice confirming that
microwave and ultrasonic diathermy devices and
ultrasound and muscle stimulator devices will remain in the most regulated
category, "Class III", if promoted or labeled for
any uses other than select medical conditions, such as relief of pain, muscle spasms,
and joint contractures. The uses of these devices do not include use for the treatment of
malignancies unless specifically approved by FDA following submission of a
Premarket Approval Application (PMA), which is the device equivalent of a new drug application.
In the same notice, FDA also stipulated that microwave and ultrasonic
diathermy devices and ultrasound muscle stimulator devices that were
commercially marketed prior to the 1976 passage of
the Medical Device Amendments and which have been found to be "substantially
similar" in a 510(k) notice to such
"preamendment" devices, are no longer exempt
from the Investigational Device Exemption (IDE) requirements when used for
clinical testing. FDA has determined that investigational class III preamendment
devices are significant risk devices and advises that as of April 14, 1999, the
requirements of the IDE regulations regarding
significant risk devices will apply to any
clinical investigation of the two diathermy and muscle stimulator devices identified
above. For any of these class III preamendment devices that are not subject to a
timely filed Premarket Approval Application (PMA)
or a Protocol Development Plan (PDP), an IDE must be in effect on or before 90 days after
the effective date of this regulation (by July 14, 1999) or distribution of the device must cease.
FDA advises all persons presently sponsoring a clinical investigation
involving any of these class III preamendment devices to submit an IDE application
to by June 14, 1999 to avoid the interruption of ongoing investigations.
FDA did not include short wave diathermy devices in the classification
notice and therefore, no PMA or PPD must be submitted for these devices at this
time. However, FDA restricts use of the short-wave diathermy devices permitted
for marketing under a premarket notification (510(k) procedure to relief of pain,
muscle spasms, and joint contractures.
FDA Commissioner Henney Testifies Before Congressional Committee on DSHEA
On March 25, 1999, Commissioner Henney testified before the
Committee on Government Reform, U.S. House of Representatives, regarding the
implementation of the Dietary Supplement Health and Education Act of 1994
("DSHEA"). In her prepared remarks, Dr. Henney
discussed the exponential growth of the dietary supplement industry since the
passage of DSHEA and the resulting challenges for FDA in implementing
the law. She reviewed the Agency's progress in developing the new regulatory
framework for dietary supplements, including recently finalized regulations on
nutrition labeling and pending proposals that
would establish good manufacturing practice requirements and define
permissible structure/function claims.
Dr. Henney informed the Committee that the implementation of DSHEA is
a high priority for the Center for Food Safety and Applied Nutrition ("CFSAN").
She has asked CFSAN to provide an overall dietary supplement strategy by the end
of 1999. According to the Commissioner, the development of this document will
involve substantial opportunity for input from
stakeholders, including the dietary supplement industry and supplement consumers.
Copies of Dr. Henney's testimony and that of other witnesses at the hearing
can be obtained from the Committee's Internet website at
http://www.house.gov/reform/hearings/index.htm.
FDA Issues Final rule on OTC Human Drug Labeling Requirements
FDA has issued a final rule establishing standardized format and content
requirements for the labeling of over-the-counter ("OTC") drug products. The
final rule, effective May 16, 1999, is intended to assist consumers in reading and
understanding OTC drug product labeling so that consumers may use these
products safely and effectively. Specifically, the
final rule establishes a standardized format to improve the readability of OTC
drug product labeling by familiarizing consumers with the types of information in
such labeling and the location of that information. In addition, standardized
appearance and content, including various
"user-friendly" visual cues, are intended to
help consumers locate and read important health and safety information and
allow quick and effective product comparisons. At present, the rule does not apply
to OTC homeopathic drug products.
In promulgating the OTC final rule, FDA highlighted the positive feedback
it received from consumers and nutritionists after redesigning food labels under
the Nutrition Labeling and Education Act of 1990. Like the food label
requirements, the new OTC drug format is intended
to offer a standardized, more organized and compact presentation, and place fewer
and less imposing demands on the reader. The final rule includes various graphic
illustrations explaining the OTC labeling outline. The applicable implementation
dates of the final rule vary according to the regulatory status of the product. The
earliest implementation date for monograph products is April 16, 2001, and applies
to products marketed under a final OTC monograph. Products that become
the subject of an approved NDA or ANDA on or after May 16, 1999 must
immediately comply with the rule.
Inspector General Issues Reports on FDA Warning Letters
The Department of Health and Human Services ("DHHS") Office
Inspector General ("OIG") recently concluded
an internal investigation of FDA's Warning Letter policies. The OIG issued two
reports concerning the investigation. The first report, entitled FDA Warning
Letters: Trends and Perspectives, OEI-09-97-00380 (Feb. 1999), focused on the
recent decrease in the number of Warning Letters, variations in district office policies,
and the regulated industry's view of the Warning Letter process. OIG reported
that FDA's more cooperative approach which permits the use of alternative
enforcement methods, coupled with better overall
industry compliance have led to the reduced number of Warning Letters. However,
the OIG report noted significant differences in Warning Letter policies at the
various district offices and stated that a firm
should not suffer adverse consequences solely because of the district in which it is
located. Nevertheless, the OIG noted that firms
are generally satisfied with FDA's customer service during the Warning Letter
process, but that the firms would appreciate
advance notice that a Warning Letter will be issued when possible. Accordingly, OIG
recommended further development of the relationship between industry and
the agency in order to preserve fairness in the Warning Letter process.
The second report, entitled FDA Warning Letters: Timeliness and
Effectiveness, OEI-09-97-00381 (Feb. 1999), addressed how FDA uses Warning
Letters and whether they are effective in ensuring compliance with Federal laws
and regulations. As a general matter, the OIG found that Warning Letters are an
effective compliance tool. Nearly 90 percent of firms responded to Warning
Letters within 15 days with a description of proposed corrective action. However,
the OIG noted that the effectiveness is directly linked to conscientious
follow-up by the agency. The report stated that,
on average, follow-up inspections took place more than 9 months after the issuance
of the Warning Letter. Likewise, the OIG stated that FDA rarely issues
Warning Letters within the 15-day period outlined in the applicable guideline and that
the district office and headquarters Warning Letter databases are not adequately
updated. Therefore, in order to increase the effectiveness of Warning Letters, the
OIG recommended that FDA improve the timeliness of the Warning Letter
process and follow-up activities, and update its data collection system to ensure that
headquarters and the district offices receive accurate Warning Letter data.
European Union Will Adopt New Rules on Genetically Modified Organisms
Looking overseas, the European Parliament approved the EU
Commission proposal to amend existing EU Directive 90/220 on the deliberate
(i.e., non-accidental) release of genetically
modified organisms (GMOs) into the environment. The proposal covers GMOs
ultimately used in the production of foods. It is
intended to clarify the rules for granting marketing authorizations and inform
consumers about the origin of the product.
However, the European Parliament introduced into the text several
amendments, including one that obligates EU Member States and the European
Commission to adopt a "precautionary principle"
(i.e., "safety first") so as to avoid adverse effects on human health or the
environment from the deliberate release of GMOs. Other amendments were
designed to enforce the strict monitoring of GMOs when they are placed on the
market. For example, a certification system was proposed whereby all GMOs
authorized for release must carry unique genetic tags, so that they can be
subsequently traced. The European Parliament also introduced the compulsory labeling of
all GMOs and a clear description of the content of the product (in this respect,
the label must not just say that the product "may" contain GMOs but must include
a more comprehensive description of the product). Another important
amendment relates to the introduction of the
producer's liability for any injuries or damages caused to human health or the
environment as a consequence of deliberate release of GMOs.
The new proposal, as amended by the European Parliament, must now
go through the next step of the co-decision procedure,
i.e., be adopted by the European Council during its next meeting
of June 24/25.
About the Author
Emalee Murphy, whose experience in
FDA-regulated industries spans over 20 years, provides regulatory
and enforcement counseling for clients in the drug
(prescription and OTC), medical device, dietary
supplement, cosmetic, food, and food additive industries, with
particular emphasis on market entry issues and strategies
for new products and new companies. She is experienced
in FDA import and export issues and provides assistance
to companies involved in FDA compliance, import
detention, and enforcement matters.
Ms. Murphy is a member
of the Food and Drug Department of McKenna &
Cuneo, LLP and practices in the firm's Washington, DC
office. She has written and spoken on a variety of FDA
related issues, most recently on the international aspects of
dietary supplement regulation.
