Huge surprise. Not.

Namaste

We learned that Senator Castor has been paying attention- asking if the committee should be doing more to make sure reimported domestic drugs from places like Puerto Rico are safe and effective. And that Dr. Sharfstein doesn’t think so, at this time.
~~~Just say Dilantin for the love of Pete.~~~

We learned that FDA wants to set markers for safety. Upgrading regulatory science.
~~~Which means what? Another change in AUC for drugs that didn’t test well under the first study?~~~

We learned that some on the committee do belive that drug makers should be better verifying the ingredients that they use (yay). And that FDA isn’t sure if it can require the implementation of Quality Risk Management Plans by those companies.

We learned that counterfeit drugs are a much bigger concern to most than the safety of legitimate, FDA approved, drugs.
Though someone did mention how people might be pushed to buy counterfeit drugs because of the inability to afford legitimate products (yay, excellent point).

We learned that FDA believes that electronic records will help them to better evaluate problems.
~~~Which would be great if doctors reported the problems properly- while FDA has a way of ignoring the reports of those silly consumers.~~~

We learned that special REMS are in place for certain treatment areas and that the REMS program is under a bit of construction. Which goes along with setting markers. And that they have some understanding of a narrow therapeutic index.
~~~Despite that understanding (or did it occur to them after the fact) they did approved the reformulation of New Look Dilantin without review.~~~

Did I miss anything? Ummm, oh, did I hear that FDA doesn’t include the required drug company payments in their budget? Seems someone was either correcting or kicking Dr. Sharfstein during that part of the discussion- so who knows. Might want to keep that in mind during the debate over generic drug user fees.

Anywho…

http://www.ahrp.org/cms/content/view/674/9/

“…it is difficult to excuse the Washington Times for its repeated selection of Dr. Ross and the ACSH…”

What a surprize. If everyone is cool with their drugs not being consistent, no longer knowing if they are going to work the same way from lot to lot, or if they might encounter a new problem because of a change in the quality of ingredients, who am I to say? Ugh! I’ve been at this for over two years.

See, when Pfizer asked us to send product to Puerto Rico so they could examine it, the answer was that the product met their quality criteria. Nevermind that the criteria had changed. FDA can inspect the plant a billion times and find everything to be fine.

I’d give up, except, damn this is important. It is also much bigger than me.

Elsewhere in the news, as many will know, Vera Shavner has sent out an “infomail” (not yet on the AHRP site) that the Wash Times issued a statement “regretting” (my translation) publishing the op ed by a convicted felon and suggesting they would be unlikely to publish another piece that came from the ASCH.

As to JaT’s concern about Kindler ot being a scientist, I hear ya’. However, he is also NOT a CPA (nor are most CEOs of public companies), but still he signs the Sarbanes-Oxley certifications.

The gist of them — and the proposed NDA certification (just conjured up by patrons99 and me!) — is that the CEO must satisfy her/himself that she/he is asking the right questions, and getting truthful answers, from an organization — with a clearly defined process for sniffing out mistakes — or worse.

If need be, the CEO can be encouraged to retain a truly independent expert to review the process, for her/him — and rely on that expert. [Bonus -- a right to work act for recently furloughed pharma science experts, reincarnated as consultants, late from Wyeth, Pfizer, Roche, Isis, Merck and Schering -- and so on!]

That the CEO can — and should — do.

We shall see.

These activities will, unfortunately continue. The reason is that not only aren’t government and markets separate, there is a direct feedback loop between them. The Wall Street folks do time in Washington, where they make sure that favorable regs are put in place. Once the favorable regs are in place, they go back to the Street, where they are able to capitalize on the favorable laws that they helped to pass. Unless this feedback loop is broken lor changed this behavior will continue ad infinitum.

The theory, which Milton Friedman and others in that school endorsed, is that the “market” is a better regulator than the feds, and that “bad actors” will fall away, while “good actors” will get out sooner.

As we know, there are a not small number of people who still believe that.