AER Follow-up: Interview with Former Harkin Chief of Staff Peter Reinecke
Written by John Weeks
Follow-up on the Adverse Events Reporting Law: Interview with Former Harkin Chief of Staff Peter Reinecke
Summary:
First as chief of staff for US Senator Tom Harkin and then as a
lobbyist associated with Pharmavite and United Natural Products
Alliance, Peter Reinecke was present at the conception and passage
of the adverse events reporting (AER) bill for the dietary supplement
industry. After the AER bill passed (see related article), the Integrator contacted Reinecke for a brief report on the process, the opposition and the meaning of the AER.
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Peter Reinecke recalls that the work on an adverse events
reporting (AER) bill for the dietary supplement industry began back in
late 2004. The two-year process, though still lacking a signature the
man who lost Florida in 2000, came to an end at 3:09 AM Saturday
morning, December 9, when the US House of Representatives passed the bill, formally called the Dietary Supplement and Nonprescription Drug and Consumer Protection Actas their last act. (See related Integrator article.)
Peter Reinecke
Reinecke was present at both ends of the process. In 2004, he was chief of staff for US Senator Tom Harkin (D-IA). With Harkin, he had been deeply involved with the development and passage of the Dietary Supplement Health and Education Act (DSHEA) in the early 1990s. Last week he was up late on behalf of two clients, the United Natural Products Alliance (UNPA) and Pharmavite, a natural products firm. The Integrator caught up with Reinecke for a short interview on Tuesday, December 12, 2006.
Integrator: So what is your sense of the value of the AER law?
Reinecke:
This is an important and needed bill that's good for consumers and
wilkl help boost confidence in the industry. It should have happened a
long time ago.
Integrator: What were the principal changes, if any, as the bill developed and the lobbying continued.
Reinecke:
The changes were more tweaking than substance. The final bill took into
account the concern of some that we would see false reporting of
adverse events being filed by (a company's) competitors. The bill that
passed makes knowingly filing a false report a violation of the law.
Integrator: Given the kinds of things we've seen from some industry members, this was likely a good addition. There was opposition from some parts of the industry I understand. Who was it? How would you characterize the opposition? Reinecke:
There was a very small but very active group. These efforts tended to
be from people who have real misgivings about the FDA (Food and Drug
Administration) and how they might use the information. I recall Julian Whitaker, MD, and Jerry Kessler (founder of supplement firm Nature's Plus) and Nutraceuticals, a firm out of Salt Lake. Some had a line of argument that causality had to be shown before a report could be filed. Integrator: That's good. Have we positively shown causality between smoking and lung cancer yet? One of the others is the American Association for Health Freedom,
which has done some good work through the years, and whose executive
director I interviewed prior to my earlier article. The note I received
from Loren Israelson (executive director of UNPA) mentioned
that a group of conservative Republicans were opposed to the bill at
the end - 94 Republicans voted against. What was the thinking?
Reinecke:
My sense was that for the vast majority of the members they didn't
really have a chance to focus on what they were voting about until the
moment of voting and some didn't have a good understanding. There were
some comments made by two Republicans, early, against the bill, that
this amounted to excessive government regulation. This is probably
behind (the "no" votes). Integrator: So, you are on your own now. Are you full-time lobbying? What are you up to?
Reinecke: I
didn't leave my job (with US Senator Harkin) because I didn't like it.
I left it because I
was tired of 80-hour work weeks. I've got a new baby. I've been giving
advice on both supplement and CAM things. I'm helping the NIH start a
new consumer-oriented magazine. I'm also doing some work for the Campaign for Tobacco Free Kids. Then there's a big chunk of free advice I give to various friends and colleagues. Integrator: Well, that's nice. I know you've been helpful to the Consortium of Academic Health
Centers for Integrative Medicine. I'll keep this in mind when colleagues and I are working under our policy hats!
Comment: We all owe Reinecke thanks for his many years
of good work, of 80-hour weeks with US Senator Harkin, and since, which have helped lay a
foundation for the better participation of natural health practitioners and products in US health care. The interview, alas, ended with the Integrator
taking up additional time from Reinecke to suggest he start planning now
to take his new baby, once grown to 5-10 years, on a nice little
working sabbatical, say Central America ...
