Here Ms. Johnson appears chary of anything involving numbers, history, politics or laws. However, she does make it clear that New England Compounding Center has been typical rather than unusual in operating more like a drug manufacturer than a pharmacy: preparing drugs in large quantities and delivering much of them out-of-state. Since federal government usually regulates both drug manufacturing and interstate commerce, that leaves unanswered the obvious question: how come? ------------------------------------------------------------------------------------------------------------ Ms. Johnson also has nothing to say here about how the compounding industry might be better regulated. It seems clear that an old-fashioned notion of compounding for individual patients is being observed mainly in the breach, that the Massachusetts Board of Pharmacy has long known about it, and that in effect there has been a silent agreement not to interfere. ------------------------------------------------------------------------------------------------------------ Ms. Johnson might have recounted the effort in 2007 by the late Sen. Kennedy to develop federal regulation via draft legislation known as the Safe Compounding Act. Trade organizations and their lobbyists organized such a vigorous campaign, stirring up a hornets' nest of hostility from anxious patients, that Sen. Kennedy never even filed the bill. Since 1998, until the bill recently announced by Rep. Markey, not a single bill addressing pharmacy compounding has been filed in Congress. ------------------------------------------------------------------------------------------------------------ [ Only a draft of Rep. Markey's bill is currently available, from the Web site of his Congressional office, at http://markey.house.gov/sites/markey.house.gov/files/documents/VALID%20Act%20legislation.pdf ] ------------------------------------------------------------------------------------------------------------ Sen. Markey's approach takes off from Section 127 of the FDA Moderization Act of 1997, which was overturned by a federal appeals court ruling in 2002. However, it differs in several ways. It does not try to restrict advertising or promotion, the basis for invalidating the 1997 law. Unlike Sen. Kennedy's proposal, it does not forbid compounding pharmacies from preparing large amounts of drugs or from delivering them without prescriptions for individual patients. ------------------------------------------------------------------------------------------------------------ Instead, Rep. Markey would allow compounding pharmacies to obtain "waivers" from the federal government for those activities. If they do that, they would have to comply with FDA "good manufacturing practices," and they would be subject to regular FDA inspections--the main elements of federal regulation. In essence, Rep. Markey proposes that when compounding parmacies behave like drug manufacturers they will be regulated like drug manufacturers.

"But over the years, some companies have grown so large that they quietly crossed a line, acting more like drug manufacturers than pharmacies that prepare drugs for individual ­patients." >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> Let's examine what you mean by "quietly". Do you mean that hospitals didn't hear about it. No, because "most of the hospitals in Mass" and "hundreds" throughout the country ordered from NECC. Do you mean that NECC was "quiet" about it. No they sent out slick brochures touting the quality of their medications. Did you mean the Mass regulators did not know about it? Perhaps, but, of course, they would have to be grossly negligent (clueless) to have not known. So, what do you mean by "quietly"? Ah, perhaps that there were few (if any) stories in the press (and none yet abut deaths). Do you mean there were few (if any) stories in the medical press and blogs? That is possible. Do you mean the FDA did not know about it? Very hard to believe. Do you mean there was not discussion in Congress? Ah, yes, it was discussed and, it seems, the subject was dropped. >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> But, you know, when regulators and Congress don't do their jobs to keep people safe, quietly or not, people sooner or later are hurt. (Just like when regulators and Congress do not do their jobs to regulate mortgage brokers, companies, and banks, eventually "stuff happens".

By the way, Bolons, excellent post (a hint: I think you have to extend the dashes to the full width of the text line to get a carriage return at the end; then the editor extends it to the whole visible page width).