Technical Analysis

Adverse Event Reporting would be created only for Serious Adverse Events. A Serious Adverse Event is defined as an experience that resulted in
(A) Death
(B) A life-threatening condition
(C) An inpatient hospitalization or prolongation of hospitalization
(D) A persistent or significant disability or incapacity
(E) A congenital anomaly, birth defect, or other effect on pregnancy, including

      premature labor or low birth weight; or
(F) Based on reasonable medical judgment, required medical or surgical  

      intervention to prevent one of these outcomes.

This language did not change in S.3546 as compared to the earlier draft of the legislation.

Reporting And Manufacturer Compliance

A manufacturer, distributor, or retailer of a dietary supplement would be required to file an AER incorporated into the existing FDA Med Watch form within 15 days of receiving a consumer notice. Under S.3546, retailers can be exempted, and distributors can be exempted, if there is agreement among the parties as to which party's address and 800 phone number is printed on the product label. This is tighter language than what was in the previous draft version of the legislation.

Upon receipt of a serious adverse experience from a person having purchased a product, the “responsible person”/company is required to file with the FDA within 15 calendar days after initial receipt of an AER. This language did not change in S.3546 as compared to the earlier draft of the legislation.

The responsible “person” must also develop and comply with written procedures for receipt, evaluation, and transmittal of AER information to the FDA. New language added to S.3546 requires that the FDA issue an industry GUIDANCE document within 1 year. This Guidance is to explain the minimum data elements that are to be included, via a revised Med Watch form, in a submitted serious adverse event report.

Filing False AER Reports

The civil monetary penalties for the “responsible person” filing false AERs remain the same in both versions of the legislation.

Exemption from AER filing

The HHS Secretary, aka, the FDA, is granted the authority to issue regulations to exempt, for example, classes of dietary supplement products. For example, supplements only composed of vitamins and/or minerals. This would require a showing that such an exemption would have no adverse effect on public health. This provision was also included in the earlier draft of the legislation.

New Information Related to an AER filing

Depending upon which entity - manufacturer, distributor, retailer - is listed on a dietary supplement product label as the “responsible person', there is a refined requirement to submit any new “medical information” associated with a submitted adverse event report, within one year of the initial report. The previous version referred to the filing of “any information”. This must also be done within 15 days of the receipt of any new medical information. It is unclear as to what would be included? Does this cover patient medical records and/or published research studies? This would have to be clarified in the Guidance document.

Maintenance of Records

The previous draft version stipulated a holding period of 7 years. S.3546 stipulates a holding period of 6 years for the “responsible person”/entity named on the labeling.

State Preemption

Both versions prevent State and local governments from enacting laws more stringent than the federal reporting requirements. The previous draft version included language to require reporting to State or local poison control centers. This has been dropped from S.3546.

Policy Analysis

With three exceptions, S.3546 is not substantially different from the earlier draft of the AER legislation.

First, there is the exemption and clarifying language on “responsible person”, i.e. company. Of course, this still leaves small supplement manufacturers on the hook, compared to larger companies. They would be required, unless otherwise agreed upon among their distributors and retailers, to have an 800 AER reporting number and a reporting address on product labels. Having your name on a product label, qualifies as a responsible party, but distributors and retailers must also have written “exemption” agreements to establish this exclusion, or something to this effect.

Second, there is the addition of the FDA Guidance requirement. This includes the third point on new medical information that must be reported, and FDA clarification on what would and would not be considered to be “new medical information”.

Apart from the matter of issuing the implementing regulations, if the legislation is enacted, the Guidance requirement can cut both ways. A Guidance document is not administrative law, nor is it enacted law. In its literal sense, it is a statement of what the FDA expects, and will be guided by. By the same token, it also opens up the FDA a more rigorous explanation of its interpretation of the law, good, bad, or indifferent. In short, drug companies have been doing a lot of things over the years, based on the argument that an FDA industry Guidance was not clear, for example.

On the process side, if enacted, there is the matter of integrating the currently voluntary reporting system into the FDA's Med Watch reporting system and having this effectively transferred into enforcement actions. For example, the FDA's own enforcement reports (for drug products) show it to be an agency under increasing pressure to do more with less. The number of warning letters issued has dropped over the past 10 years even as product recalls have increased. In other words, the agency is allowing more manufacturer product mistakes to reach the market. The basis for these actions is the current Med Watch program. Adding supplements would, in my view, reduce enforcement efficiency even more - for drugs and supplements- absent more FDA financial resources in the future. A classic example of the federal government wasting money to protect the public from a relatively small health threat.

What is clear is that if this Senate bill is approved and enacted into law, there will certainly be more regulatory confusion, and cost, associated with supplements. The cost consideration does not take into account the prospect, if enacted, of future dietary supplement User Fees being imposed on the industry and, indirectly, upon dietary supplement consumers.

Political Situation

Given the key HELP Committee sponsors of the bill, getting it out of committee is not an issue. Getting it scheduled for a committee vote/markup is a separate consideration. Staffs indicate that it could be acted on. After the July 4th recess, the Senate will be in session for a month, out for August, and back in session for another month, before recess for the elections. Not much time, but it does not take much. This is what Unanimous Consent Agreements are for.

As for full Senate passage, in this case, if voted out of the HELP committee, there is the prospect of having UC passage on the floor of the Senate. However, this still has to be agreed to by the floor bill leader, in this case, Senators Hatch or Enzi, and collectively Senators Frist, Reid, and Durbin. This could occur before the election recess. If not, there is still the prospect of a post-election Lame Duck session to pass “must pass” bills, and other “non-controversial” bills.

Even if S.3546 stays in the HELP Committee until the election recess, this does not mean that it is necessarily dead if a Lame Duck session is convened. According to Senate staff, Senators Hatch and Harkin are not strongly opposed to moving the legislation out of committee. As regards to full Senate approval, this is an issue that will be addressed at the appropriate legislative process point in time, if at all this year.

 

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