Awkward

Oh dear. All those politically-connected prescription management companies (the ones who deny you anything but generic drugs under your health insurance) will have their lobbyists working overtime on this one. Why, you’d almost think the FDA didn’t want to find a problem! (And this is yet another reason why single-payer is the only logical choice to control costs.)

The Food and Drug Administration took a highly unusual step this week: It acknowledged that a widely used generic drug — a copycat of the antidepressant Wellbutrin XL — was not the equivalent of the original drug produced by GlaxoSmithKline since 2003.


The move prompted the world’s largest manufacturer of generic drugs, Israel-based Teva Pharmaceuticals, to stop shipping its generic extended-release bupropion — marketed as Budeprion 300 mg XL– and to remove it from U.S. shelves.


The FDA finding marks an about-face for the food and drug safety agency, which in 2009 responded to public concerns by flatly declaring Teva’s Budeprion XL “bioequivalent and therapeutically equivalent to (interchangeable with) Wellbutrin XL 300 mg.”


The agency’s reversal came after a five-year kerfuffle that has called into question its unqualified assertion that all generic medications work exactly as the more costly “pioneer drugs” they are intended to mimic. With millions of American patients switched — often without notification — to newer, cheaper forms of the drugs they take, this week’s acknowledgment by the FDA may open a small chink on the agency’s so-far impenetrable armor on generic drugs.


“The FDA is not infallible,” write Joe and Terry Graedon, who publish the column “The People’s Pharmacy,” and run an online forum by the same name. “Just because the agency says all generic drugs are identical to their brand-name counterparts does not make it so.”


The Graedons, whose column long ran in The Los Angeles Times, say they have also collected “a great many other complaints” about the generic forms of the beta-blocker Toprol XL (metaprolol) and the anti-seizure drug Keppra (levetiracitam), and have urged the FDA to look into them.

The infield fly rule

Oh God, the infield fly rule! It took me a while to learn this one, and I imagine that this morning, the Braves fans wish it never existed. And by the way, it does look like a bad call:

A week and a half after a blown call by replacement referees on “Monday Night Football” sparked a national outcry, baseball’s umpires ignited similar outrage Friday with a controversial call that marred the St. Louis Cardinals’ 6-3 victory over the Atlanta Braves in the National League wild-card game at Atlanta.


Trailing, 6-3, with runners on first and second in the eighth inning, the Braves appeared to catch a break when an Andrelton Simmons fly ball to short left field dropped between Cardinals shortstop Pete Kozma and left fielder Matt Holliday after a mix-up over who had it.


A crowd of 52,631 roared, assuming the bases would be loaded with one out and Brian McCann, a .339 hitter with nine grand slams in 109 at-bats with the bases loaded, on deck.


But just before the ball dropped, left-field umpire Sam Holbrook signaled an automatic out because of the infield fly rule, which is designed to prevent a team from intentionally dropping a popup in order to get extra outs with more than one runner on base.


Atlanta Manager Fredi Gonzalez argued vehemently, claiming the ball fell a good 50 feet beyond the infield and could not have been caught “by an infielder with an ordinary effort,” which the rule requires.


Fans littered the field with hundreds of plastic bottles and other garbage, causing a 19-minute delay, during which Gonzalez filed an official protest that was later denied. Infield-fly rulings are not reviewable by instant replay.

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