Friday, May 11, 2007

Senator DeMint Lied, [Senate] People Authorized

Recently the Senate approved bill S. 1082: Prescription Drug User Fee Amendments of 2007, which deals mostly with post-marketing FDA drug regulation.

The bill is brimming with amendments, ranging from the sale of turtles, to the regulation of RU-486 (Mifeprex). Turtles are cute, but what interests me is the RU-486 (Mifeprex) amendment. [Quelle surprise, I know.]

The way I found out about the RU-486 (Mifeprex) amendment and its sponsor, Senator Jim DeMint (R-South Carolina), was via an email from the ACLU, which included a link to Sen. DeMint's press release announcement. I read it and realized it was full of lies.

Not understanding how lies can be the basis for legislation regulating the availability of drugs I called one of the bill's sponsors, Senator Mike Enzi, (R-Wyoming) to ask for an explanation.

Before we go on, can you spot my mistake?

I spoke with a staffer in Sen. Enzi's office. She was familiar with the bill, but not so much with Sen. DeMint's amendment. All she could tell me was that there was only one amendment with his name on it, 1018, and its title: To amend the notification provision with respect to drugs deemed to have risk evaluation and mitigation strategies. No point in discussing the substance of a piece of legislation, when you're not even clear on what legislation it is you want to talk about. I thanked the staffer for her help, and went back to the drawing board. [Learn from my mistake: Always check your primary source/s.]

I located the full version of S. 1082: Prescription Drug User Fee Amendments of 2007. Here's the section affected by Sen. DeMint's amendment:

(3) NOTIFICATION- Not later than 30 days after the effective date of this subtitle, the Secretary shall notify the applicant for each drug described in paragraph (1)--

(A) that such drug is deemed to have an approved risk evaluation and mitigation strategy pursuant to such paragraph; and (B) of the date, which, unless a safety issue with the drug arises, shall be no earlier than 6 months after the applicant is so notified, by which the applicant shall submit to the Secretary an assessment of such approved strategy under paragraph (7)(B) of such section 505(o).


From the Congressional Record for the Senate on May 2, 2007, Sen. Jim DeMint's amendment, S.Amdt. 1018: To amend the notification provision with respect to drugs deemed to have risk evaluation and mitigation strategies., offered May 2 2007 and agreed to in Senate by Unanimous Consent:

SA 1018. Mr. DeMINT (for himself, Mr. Inhofe, Mr. Brownback, Mr. Martinez, Mr. Vitter, and Mr. Coburn) submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; as follows:

In section 214(b)(3)(B) of the bill, insert ", except with respect to the drug Mifeprex (mifepristone), such assessment shall be submitted 6 months after the applicant is so notified" before the period at the end.


According to Sen. DeMint's press release (emphasis mine):

May 2nd, 2007 - Washington, D.C. - Today, U.S. Senator Jim DeMint (R-South Carolina) applauded the unanimous approval of his amendment to 1082, the FDA Reauthorization Act, which would require the FDA to assess the Risk Evaluation and Mitigation Strategy (REMS) for RU-486 within seven months of the bill’s effective date. The amendment was accepted by voice vote, which mandates that RU-486 be subject to assessments of how well the risk management plan, including its restrictions, is working.


Sen. DeMit says his amendment would require the FDA to assess the Risk Evaluation and Mitigation Strategy (REMS) for RU-486 within seven months of the bill’s effective date.

Either I misunderstand what the original bill and the Senator's amendment say, or Sen. DeMint is, once again, lying.

Let's examine the first possibility, shall we?

The text of the original bill says that no latter than 1 month (note, 1 mo) after the bill takes effect, the FDA shall notify the drug's manufacturer of the date by which the pharma company shall submit to the FDA an assessment of the risk evaluation strategy [Risk Evaluation and Mitigation Strategy (REMS)]. This date shall be no earlier than 6 months (note, 6 mo) after the pharma company is notified that it has to submit the assessment.

1 month + 6 months = 7 months.

My understanding, made possible in great part by my most advanced mathematical skills, is that the original bill would have required the FDA to assess the REMS for a drug, like, for example, RU-486, within 7 months of the bill's effective date.

What about Sen. DeMint's amendment, the very one which causes him to burst into fits of self-congratulatory applause? Will my, by now mythical, familiarity with math help me understand the Senator's amendment? This is how the amendment changes section 214(b)(3)(B):

(3) NOTIFICATION- Not later than 30 days after the effective date of this subtitle, the Secretary shall notify the applicant for each drug described in paragraph (1)--

(A) that such drug is deemed to have an approved risk evaluation and mitigation strategy pursuant to such paragraph; and (B) of the date, which, unless a safety issue with the drug arises, shall be no earlier than 6 months after the applicant is so notified, by which the applicant shall submit to the Secretary an assessment of such approved strategy under paragraph (7)(B) of such section 505(o), except with respect to the drug Mifeprex (mifepristone), such assessment shall be submitted 6 months after the applicant is so notified.


Applying the same analysis we did to the original bill, the text of the amended bill says that no latter than 1 month (note, 1 mo) after the bill takes effect, the FDA shall notify the drug's manufacturer of the date by which the pharma company shall submit to the FDA an assessment of the risk evaluation strategy [Risk Evaluation and Mitigation Strategy (REMS)]. With the exception of one drug, Mifeprex, the submission date shall be no earlier than 6 months/6 months (note, 6 mo) after the pharma company is notified that it has to submit the assessment.

For all drugs, except RU-486 (Mifeprex): 1 month + 6 months = 7 months.

For RU-486 (Mifeprex): 1 month + ?

As far as I can tell Sen. DeMint's amendment does the exact opposite of what the Senator claims it does. It removes the requirement that the FDA assess the REMS for RU-486 (Mifeprex) within 7 months of the bill's effective date. It's not clear how long the RU-486 (Mifeprex) manufacturer has to submit its assessment since the amendment doesn't specify. [Ah, vagueness, the very thing you want when it comes to drugs and your health.] It could be 30 minutes, or 8 days. Who knows? The drug's manufacturer, the patients, we all exist to serve at Sen. DeMint's pleasure and command.

Bottom line: Sen. DeMint lies about the need to single out RU-486 (Mifeprex) for separate, propaganda-based regulation, his amendment does the exact opposite of what he claims it does, and not a single one of his illustrious colleagues is professional enough to challenge Sen. DeMint's dereliction of duty (assuming, of course, lying has not yet become a job requirement for the hallowed halls of Congress denizens).

Next, we'll analyze Sen. DeMint's lies remarks in support of his amendment. [Here, and here.]

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2 Comments:

At 6:26 PM, Anonymous oliviacw said...

I think the admendment is ambiguous. I see how you got your reading, which is that all drugs should have the assessments submitted within 6 months, except for Mifeprex. On the other hand, my initial parsing was that all drugs have no less ("date shall be no earlier") than 6 months (and possibly more) to submit their assessment, with the exception of Mifeprex, which gets 6 months and no more. It depends on whether you read the "except" as beginning the terminal clause (my reading), or as an embedded clause.

I think mine reading is probably what was intended, otherwise the "no earlier than 6 months" is contradictory to the "shall be submitted 6 months after".

 
At 11:59 PM, Blogger ema said...

oliviacw,

I see, maybe something along these lines:

...except with respect to the drug Mifeprex (mifepristone), FOR WHICH such assessment shall be submitted 6 months after the applicant is so notified.

I agree it's a possible interpretation (and it would resolve the no earlier than 6 months/6 months after problem), but it requires we trust that that's what Sen. DeMint intended.

After spending most of the day exposing all the blatant lies in the remarks the Senator offered in support of this amendment [posts forthcoming], I'm not inclined to believe anything this person says or does.

 

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