Industry hails bill on adverse events reporting

By Jess Halliday

- Last updated on GMT

Related tags: Adverse events, Dietary supplement

An amendment to the Food, Drug and Cosmetic Act that would obligate
supplement manufacturers, packers and distributors to notify FDA of
any serious adverse events reports (AERs) was introduced yesterday,
to the applause of the industry associations.

Senate bill 3546, the Dietary Supplement and Nonprescription Drug Consumer Protection Act, is sponsored by Republican Senator Orrin Hatch and Democrat Senators Tom Harkin and Dick Durbin.

It will require supplement labels to include a telephone number for the reporting of serious advert events, and require supplement companies to pass on these reports to FDA within 15 days.

For its part, FDA would be obligated to consolidate multiple reports of the same incident, and retain records for six years. Individual states would be precluded from establishing their own AER systems.

The industry opposed the introduction of an AER bill in the state of California in 2004 on the grounds that it covered minor, as well as serious AERs, and would have been financially burdensome for supplement companies.

Steve Mister, president and CEO of the Council for Responsible Nutrition, told NutraIngredients-USA.com that the industry associations have had a seat at the table throughout the process, and the senators have shared drafts with them.

The bill has been in the works for the past year, and a meeting was held at Expo West in Las Vegas last autumn at which the associations explained the rationale behind supporting the bill to the industry at large.

The news of the bill's introduction was also welcomed by the National Nutritional Foods Association (NNFA) and the American Herbal Products Association (AHPA).

The NNFA issued a statement saying that it believes the bill "represents a fair and meaningful collaboration among the supplement industry, our bi-partisan champions in the Senate, and legislators who would like to see more stringent oversight of dietary supplements".

The dietary supplements industry is regulation by DSHEA, the 1994 Dietary Supplements Health and Education Act (also an amendment to the Food, Drug and Cosmetics Act). This law has drawn criticism from some quarters since it does not require the same pre-market approval for supplements as is necessary for prescription drugs.

However adverse events are by no means only associated with safety of specific ingredients; they might also stem from supply chain issues, contamination or tampering.

By having the FDA collate all adverse events, the government agency may be able to identify patterns that would lead to the source of a problem being identified, such as tracing it back to a common supplier. Such patterns might not be immediately evident to manufacturers dealing with isolated or few incidences.

Mister also pointed out that premarket testing is not a catch all for safety problems, as has been seen with issues over Vioxx and other drugs in the past.

The 15-day window to pass on reports associated with supplements or OTC drugs to FDA allows for a very quick response.

As for why the bill is being introduced now, 12 years after DSHEA, Mister said that the industry has matured in the intervening years. It wants to be respected and recognised, and is aware of its obligation to consumers.

"In the last 12 years, the FDA and the industry have recognised more and more the importance of adverse events, understanding that things happen in the market that you may not expect when preparing for market,"​ said Mister.

He added that the case of the banned herbal ephedra also has a lot to do with it; in the late 1990s a company received a number of AERs relating to ephedra but these were turned over to the FDA only when it was issued a subpoena.

"That started the industry thinking that we need to be credible about this."

AERs are defined only as health-related events resulting in death, a life-threatening experience, inpatient hospitalization, persistent or significant disability or congenital abnormality or birth defect. As such, the industry is expecting a low incidence of reports lodged with the agency - yet to prove this it has to put its money where its mouth is.

Some concern has been raised from within the industry that the collation of AERs will make it easier for plaintiffs' attorneys to bring law suits against the industry, however a mechanism has been built in to protection against this; namely.

AHPA president Michael McGuffin said: "Marketers of [supplements] can be certain that they will be provided with the same kinds of protection that the pharmaceutical industry enjoys, so that this system does not penalize companies that comply"​.

The bill includes language to make it clear that reporting an AER to the FDA "shall not be construed as an admission that the dietary supplement involved caused or contributed to the adverse event"​.

It would also be illegal to file a false AER report.

The bill is being immediately to the Health, Education, Labor and Pensions (HELP) committee, and a mark-up session has been scheduled for next Wednesday.

From there the timescale becomes less clear, but Mister said: "We are hopeful it could be on the President's desk by the end of the year."

Related topics: Regulation

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