Elsewhere ingredients were at issue. Noted as contaminant the prescription (viz controlled use) drug phenazepam present. Whose presence was what I'd refer to as a likely story( viz excuse).
How come..? What of controls.? Is it one thing to legislate for controlled substances and quite another to expect satisfactory knowledge in commercial profitmakers from such substances? In whom are satisfactory use standards mandated and/or obligatory?
More than interesting is what the New Zealand Drug Foundation director, Ross Bell, had to say on the subject:—
"The trouble with our drug laws is..the onus is on the government to prove a new product is harmful, rather than a manufacturer prove it is safe."Looks a market-ready recipe for make and sell..what the hell!
Then a surprise when a commenter told of how NZ was the only other country (cf USA) to operate DTC (direct-to-consumer) advertising on non-prescription, or controlled, drugs.
If true, then free market practices have hit upon one major obstacle in the form of uncontrolled and, as the case may be, unacceptable drugs demand.
For myself, a smoking quitter now at least two decades mature, I'd call unacceptable. For reasons related to how consequential costs shall fall upon others in need of health dollars in a very zero sum budgetary scheme of things post-recession and/or recession-strapped.
Okay, so for me there's a case to answer. How does one do this..?
Tell them about the Hearing.. y'know Woodcock—no not Woodstock—I said Doc Woodcock didn't I.. go on..!
Yes, Perjjo, you were rather impressed with her weren't you.. okay..I'll mention it though I can't remember all the points..
She's the point, just remember that—
At the Energy and Commerce subcommittee Hearing
Backstory to the meeting included in part the heparin crisis of 2008. Briefly:—
The discovery of a contaminant* in batches of heparin throws into stark relief the difficulties, not only for the US Food and Drug Administration, but also for international regulatory agencies, to ensure the safety and quality of active pharmaceutical ingredients.Riven with political partisanry and polarisations the US in recent years has made little progress on such matters. Added to which Republicans have backed aggressive budget cuts to FDA, whilst requiring it relax scrutiny of new drug approvals and conflicts of interest.
Before them a bill - HR 1483 - the Drug Safety Enhancement Act. Needed was informed evidence on where the FDA was at so as to close gaps. Related, I gather Tom had spotted a p/release and jotted the salient, and to the extent of expanding what the agency would be about in broad global collaborations, I think the proceedings useful.
On message Rep. Waxman said: “It is in no one’s interest to have a weak FDA.. If Americans lose confidence in the FDA, they will lose confidence in the pharma industry as well. The FDA needs the resources to protect us for(sic) unsafe drugs, and to be sure these drugs work.”
Firm for the FDA, Dr. Janet Woodcock, positively shone:—
".. the agency's job is to keep patients safe, and make sure drugs work.. It is an important piece of the innovation pipeline, not an impediment".
Wow! Whoever would have thought responsible regulation in the food and drug industry was an impediment? No, don't tell me, let me guess ;-)
Far from overcome by the insight several Hearing members argued that a "dry drug pipeline" was the FDA's problem. Woodcock countered immediately, "Safety problems were not the sole province of generic drug makers.. "Heparin was not a generic drug.. This is not a generic drug problem–this is a pervasive drug quality problem".
Hi, Perjjo again: I've gotten the feeling this lady sees the past as a foreign country.. know what I mean? Roll on the future..
She was not done either. Rep Dingell explained to all present how the next session would be rapid fire Q&A—like he was rapid Q and she rapid A..
His first ten getting short solid noes. Because this frames the nature of HR 1483 I'll include five of them as follows...
Do you have —
- ability to control the safety of pharma imports into the US?
- necessary resources to ensure raw materials suppliers do GMP**
- authority to recall drugs you believe to be substandard or unsafe
- power to refuse suspected adulterated imports at the border
- ability to share matters with trusted regulatory partners
So.. let me see, saith Rep. Dingell — it's a nine year frequency for visiting foreign drug manufacturing facilities.. and a one year frequency for dog food making facilities.?
Yes.
Do you(FDA) need these additional authorities and would HR 1483 have afforded you need to deal with the heparin problem?
Absolutely, yes.
Do it America, and collaborate internationally without getting too hung up over drug "counterfeiting" etc. This needn't mean a return to the - lucky you! - trade protection regime that so very fortunately avoided much thalidomide tragedy - but needed is to re-enable capability for demanding responsible and obligations-led pharmaceutical and biopharmaceutical global business.
* The heparin was made in China, which like the melamine contamination of milk had prior 'approval' because ** good manufacturing practices were not or had not been observed and a critical number of casualties in the market took time to build up and get noticed.
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