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Adverse event reporting mandated for
supplements, OTCs
Manufacturers, packers, and distributors will have
15 days to notify FDA of serious harm associated with use of their
products; requirements take effect next December.
Just before Congress went out of session last weekend, the Senate
passed legislation that will require companies that make and distribute
dietary supplements and OTC drugs to inform federal authorities about
serious adverse events among users of their products. The Dietary
Supplement and Nonprescription Drug Consumer Protection Act (S. 3546)
would also require the manufacturer, packer, or distributor whose name
appears on a product’s label to include its address or phone
number on the label.
President Bush is expected to sign the legislation later this month, and
it will become enforceable 1 year after it is signed.
Sen. Orrin Hatch (R-Utah), who introduced the bill in June, said,
“This new legislation complements the 1994 supplement law [the
Dietary Supplement Health and Education Act] I authored by providing
federal authorities with an additional tool to identify when serious
problems occur.”
When S. 3546 takes effect, supplement and OTC drug companies will have
to notify FDA within 15 days of learning of patient harm resulting from
one of their products. Companies will use MedWatch forms to make reports
and will also have to submit follow-up reports on new medical
information in individual cases. Product labels must be submitted with
adverse event reports, and companies making the reports must keep copies
of all filings for 6 years.
The law defines a serious adverse event as “death, a
life-threatening experience, inpatient hospitalization, a persistent or
significant disability or incapacity, or a congenital anomaly or birth
defect” that occurs or must be prevented by a surgical or medical
intervention also falls under the definition of serious adverse
event.
The U.S. Department of Health and Human Services will issue more
complete guidance by the end of August 2007. Failure to comply with the
reporting and record-keeping requirements could result in prison
sentences of up to a year and fines up to $1,000 for each offense.
APhA CEO and Executive Vice President John Gans, PharmD, welcomed the
new law as an important step for protecting patients’ health.
“APhA has encouraged additional oversight of dietary supplements
for years,” he said. “Encouraging health care professionals,
manufacturers, and consumers to report adverse health events associated
with dietary supplements will help pharmacists help patients get the
best from supplements and avoid potential problems.”
Rep. Chris Cannon, who is also a Republican from Utah, sponsored the
companion bill to S. 3546 in the House. It is telling that the mandatory
supplement adverse event reporting law was championed by lawmakers from
Utah. The Beehive State is home to the largest number of dietary
supplement makers in the United States, and in November 2003, the
magazine Utah Business reported that 20 of the state’s
largest 25 public companies made supplements.
S. 3546 drew strong support from the American Herbal Products
Associations, the Center for Responsible Nutrition, and the Consumer
Healthcare Products Association (CHPA). In a press statement, CHPA
President L inda A. Suydam , DPA, s aid her organization “ looks
forward to seeing mandatory adverse event reporting for all OTC
medicines and nutritional supplements become a reality. In addition to
bolstering public confidence, the establishment of a mandatory system
also will benefit manufacturers by standardizing the scope and extent of
reporting to FDA."
Web links
Related resources on www.pharmacist.com
Contact the writer: Ed Lamb, Pharmacy Today
Posted December 14, 2006, 4:30 pm EST
| Manufacturers, packers, and distributors will have 15 days to notify FDA of serious harm associated with use of their products; requirements take effect next December. |
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