Mandatory adverse events reporting for supplements is on the way

At an educational session at SupplySide West in Las Vegas on Friday, the heads of the National Nutritional Foods Association (NNFA), Council for Responsible Nutrition (CRN) and American Herbal Products Association (AHPA) sent out a united message in support of adverse events reporting (AER).

Despite previous bills that would have made AER mandatory for supplements, there is no legislation currently in the works. It is hoped that a bill will be introduced soon, possibly even before the end of the year.

The matter is particularly pertinent following last month's publication of a report from the New York State Task Force on Life & the Law, entitled 'Dietary Supplements: Balancing Consumer Choice and Safety'.

Session moderator Marc Ullman, of Ullman, Shapiro and Ullman, said that the task force urges the government to take draconian action against the industry, claiming that dietary supplements are not safe enough, effective enough, or regulated enough.

In particular, it criticized the 1994 Dietary Supplements Health and Education Act (DSHEA) on several counts, including that it contains no requirement for manufacturers to report adverse events associated with dietary supplements to the FDA or any other body.

Although the industry associations agree that AER is a good idea for the industry, Ullman drew attention to a number of inaccuracies in the report. These include the assertion that consumers use supplements for serious diseases like herpes, HIV and cancer, while in fact it is illegal to market supplements with disease claims.

The report also says that some supplements are sold as street drug alternatives - another illegal marketing claim - and that supplements can be easily bought over the Internet by children. This latter accusation can be leveled just as equally at pharmaceutical products.

Ullman said that a scientific and legal rebuttal to the mistakes and misstatements is being prepared by NNFA East and a draft is expected to be ready by the beginning of December.

"This is an influential task force,"​ said Ullman, noting that previous recommendations made by the New York State Task Force on Life & the Law have led to legislation in a number of states - not just in New York.

However the industry associations would prefer to see legislation on AER enacted at a federal, rather than a state level.

AHPA president Michael McGuffin said: "There is a need for federal legislation that really addresses the industry's needs."​

"The industry has to take the stick out of the hands of critics and the media, and it wouldn't take much to do it. If handled carefully, it would not harm the industry."​

The concern is that state-by-state legislation may not contain adequate protections for manufacturers. According to McGuffin, it should relate to serious adverse events only, AER submission should not be seen as a causal admission, and the identity of a subject and any associated parties should be protected - not least because this would prevent them from being targeted by plaintiffs' attorneys touting for business.

For Rx drugs, medical devices and some over-the-counter (OTC) drugs reporting by manufacturers is mandatory. AER for supplements and some OTC drugs, such as aspirin, is voluntary, but Steve Mister, president of CRN, said that the FDA already receives a lot of reports through channels like CAERS, Medwatch and FDA District Coordinators.

The task force report claims that only 1 percent of AERs associated with supplements are getting through, but the associations maintain that this is a vast underestimate.

"No-one is pulling the wool over FDA's eyes now,"​ said Mister. "It is hard to believe that the flood gates will open just because manufacturers have to do what many say they are already doing anyway."​

"It is not about incentivizing consumers to generate more AERS. It is about requiring manufacturers to inform FDA of the AERs they already receive."​

He added that mandatory AERs would function as an early warning system for potential problems. Even in the case of drugs, which are much more heavily regulated, clinical trials are not a catch-all and some effects may show up only when the products are out in the real world.

Mandatory, federal system means that AERs may show trends across brands. They are helpful for developing hypotheses; in themselves, they do not constitute proof as we do not know what else people may be using.

"We need to be quite clear when talking about AERs that they don't prove causality."​

This is an important point, as it would prevent manufacturers making a judgment call on causality and screening out reports that it does not believe are caused by its products.

Moreover, AERs are not just about safety. They also show up issues like adulteration or tampering at plants, manufacturing issues and bio-terrorism, the FDA needs to know about it.

Mister ran through a number of other points on the industry's wish-list for mandatory AERs:

They should relate only to serious AERs - that is, death, a life threatening experience, inpatient hospitilization or prolonging of existing hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect.

"We are not talking about consumers calling up saying 'my tongue turned purple for a couple of hours after I took a purple-colored pill',"​ he said;

All OTC drugs should also have mandatory AERs, and the relevant association for the pharmaceutical industry has signaled its agreement; there should be a limit to domestic reports only; and contracting out to third parties should be permitted, as many drug companies currently do.

Finally, he explained that it is not enough to just put the MedWatch number on packaging, since consumers would call FDA directly. Not only would this encourage over-reporting of non-serious events, but a manufacturer might not know for some time that a report has been filed.

This delay would mean that the manufacturer would not be able to take steps to solve any supply or plant problems that showed up as quickly.

"Mandatory adverse events reports are inevitable. It may not be this year, it may not be next year, but it is coming and I think it is the right thing to do,"​ said Mister.