Called the FDA Safety and Landmark Advancements (FDASLA) Act, the bill comes out of the Senate HELP (Health, Education, Labor and Pensions) Committee and bears the names of Chair Sen. Patty Murray (D-WA) and Ranking Member Sen. Richard Burr, (R-NC). As of publication time the bill is under debate and the fate of Romney’s amendments has yet to be decided.
The bill reauthorizes FDA’s prescription drug, generic drug, biosimilar, and medical device user fee agreements. Significantly, however, it is also contains provisions meant, in Sen. Murray’s words, to “provide long overdue oversight of cosmetics and dietary supplements.”
Such fee reauthorization bills are generally boilerplate affairs that generate little to no controversy. Indeed, a House reauthorization bill, which does not contain dietary supplement provisions, passed last week on a 392-28 vote.
Bill sets out new listing requirements
That’s why some in the industry have viewed with concern the tacking of the supplement provisions onto a bill that’s sure to pass in one form or another. It’s something akin to the practice of trying to slip in not very closely related riders into bills funding basic Federal government operations, which must be passed at some point.
The portions of the bill aimed at dietary supplements would require manufacturers to submit a listing of the product to FDA prior to going to market. The bill has eight individual citations relating to this requirement. As the bill’s language stands at the moment, products that don’t comply with the listing requirement would be judged to be misbranded.
It’s the second recent major piece of legislation to propose a mandatory product listing requirement be added to federal law. The other was a bill introduced by Sen. Dick Durbin, D-IL and Mike Braun, R-IN back in April.
Unacceptable precedent
Romney’s six amendments propose tweaks to the language of the bill, but the whole is still is still unacceptable, said Daniel Fabricant, PhD, president and executive director of the Natural Products Association. NPA has consistently argued against any form of mandatory product listing, which is one of the modifications that have been proposed to the Dietary Supplement Health and Education Act within the general ‘DSHEA 2.0’ discussions. The idea has won some support within the industry, though the particulars of the Murray/Burr bill have not.
“We’re back to square one. All this was was a negotiating tactic. Put bad stuff in the bill and then get it removed so that people think they’re getting a better deal. It’s the same bill the majority of the industry opposed months ago in the Braun/Durbin bill,” said Daniel Fabricant, PhD, president and CEO of the Natural Products Association.
Leadership vacuum presents threat
Fabricant speculated that one of the reasons such bills can go forward is the lack of strong representation for the industry on Capitol Hill. The retirement of Sen. Orrin Hatch, R-UT (and the earlier retirement of Sen. Tom Harkin, D-IA) has left a power vacuum for the industry on the Hill that has yet to be filled.
In the past, sponsors of a bill that included provisions bearing directly on the dietary supplement industry would have had to reckon with Hatch’s reaction. His long tenure in Congress had given Hatch considerable power.
Now, Fabricant said, each such battle has to be fought anew. And, while it’s pure speculation, it’s easy to imagine there is a pent up demand for dietary supplement legislation from some longtime foes of the industry in Congress who can now move forward knowing that Hatch no longer sits astride the road.
The path to premarket approval
Fabricant said without specific language prohibiting it, a mandatory product listing requirement such as the one called for in the Murray/Burr bill could easily morph into a form of premarket approval.
“We started down this path with the Braun/Durbin bill,” he said. “Most of the industry thought there was a lot that could go wrong.”
“Now more has gone wrong. This bill is just a gift for the plaintiff’s bar. We have policy and process considerations. What’s the process by which FDA could remove or deny a listing? Could they say, ‘CBD is not a dietary ingredient.’ Could they say the same thing for NAC?” Fabricant said.
