As readers may know, I’ve been beating the drum for a while on the increasingly dangerous shortages that doctors are encountering in the availability of common, off-patent drugs used in hospital and clinical settings, including drugs that are important in chemotherapy, anesthesia, and infection control. Among the reasons for the shortages: the Food and Drug Administration has toughened its regulation of pharmaceutical makers in ways that lead to manufacturing line shutdowns and withdrawals from production.

John Goodman has a must-read blog post at Health Affairs Blog on the mounting crisis, amplified by a post by George Mason economist Alex Tabarrok at Marginal Revolution, getting into further specifics. In particular:

• 246 drugs are now considered to be in shortage, a record high, and the number has been rising for years. Rationing of scarce chemotherapy drugs is now making a difference in which patients have a chance at survival. In the absence of familiar compounds, doctors are falling back on inexact substitutes, sometimes more dangerous and less effective.

• After “tainted drugs” scares a few years ago, the FDA stepped up its Good Manufacturing Practice regulations, which control the production of pharmaceuticals. In particular, it now proclaims zero tolerance, barbed by tough fines, for many technical infractions whose actual impact on patient risk is at best doubtful, and it is unafraid of shutting down production lines again and again for retooling until its regulations are satisfied to the letter. It also changes its formulation and manufacturing requirements often, with scant forgiveness for makers who have trouble retooling to the new specifications quickly.

• Remarkably, the feds have inserted themselves into the role of central planners of drug output. Goodman:

For example, a drug manufacturer must get approval for how much of a drug it plans to produce, as well as the timeframe. If a shortage develops (because, say, the FDA shuts down a competitor’s plant), a drug manufacturer cannot increase its output of that drug without another round of approvals. Nor can it alter its timetable production (producing a shortage drug earlier than planned) without FDA approval.

That the results might include many unpleasant surprises will surprise only those unfamiliar with the record of a century of central planning failure.

• Pre-1938 drugs are suffering particular disruptions because of a separate FDA program, long demanded by consumer groups, to subject these “grandfathered” compounds to regulatory oversight just as tough as newer drugs. The dictates of the Drug Enforcement Administration also contribute to problems with some controlled substances.

• Several leading professional organizations, including the American Society of Anesthesiologists and the American Society of Clinical Oncology, collaborated on a meeting last November to raise the visibility of the issue and seek possible solutions. You can read its summary report here. Objectively, it’s a damning indictment, but be warned that — rather typically in a field where many key players live in fear of offending the FDA — the report refrains from outspoken criticism of the agency and in fact proposes widening the agency’s funding and powers.

Wouldn’t this make a good subject for hearings at the newly Waxman-liberated House Commerce Committee?

A Hospital Drug Shortage Made In Washington is a post from Cato @ Liberty - Cato Institute Blog

In 1995, shortly after becoming Speaker of the House, Newt Gingrich mulled a radical overhaul of the U.S. Food and Drug Administration.  As he put it to a room full of health insurers, “Maybe we’ll take out FDA.”

What made Newt likable to advocates of freedom is sadly no longer part of his schtick.  Here’s how Andrew Stiles reports on Newt’s appearance on Meet the Press yesterday:

“I don’t think right-wing social engineering is any more desirable than left-wing social engineering,” he said when asked about [House Budget Committee chairman Paul] Ryan’s [R-WI] plan to transition to a “premium support” model for Medicare. “I don’t think imposing radical change from the right or the left is a very good way for a free society to operate.”

As far as an alternative, Gingrich trotted out the same appeal employed by Obama/Reid/Pelosi — for a “national conversation” on how to “improve” Medicare, and promised to eliminate ‘waste, fraud and abuse,’ etc.

“I think what you want to have is a system where people voluntarily migrate to better outcomes, better solutions, better options,” Gingrich said. Ryan’s plan was simply “too big a jump.”

He even went so far as to compare it the Obama health-care plan. “I’m against Obamacare, which is imposing radical change, and I would be against a conservative imposing radical change.”

If you close your eyes, it’s like listening to The Princess Bride. Medicare and Medicaid are nothing if not social engineering.  So by Newt’s logic, we should get rid of them.  But Newt also says that radical change is bad, which means we can’t.  That leaves incremental changes.  But incremental changes to massive social-engineering experiments are themselves social engineering, so we clearly cannot make incremental changes, either.  ObamaCare is both social engineering and radical change.  Again by Newt’s logic, ObamaCare is bad, and we must get rid of it, but we can’t.  Truly, he has a dizzying intellect.

Newt’s objection to Paul Ryan’s Medicare reforms is no less incoherent.  It appears to be that the reforms approved by the House would eliminate the traditional Medicare program as an option for Americans who enroll after 2021.   So far as I can tell, Newt’s opposition to this feature is consistent with his past positions on Medicare reform.  He wants to let people stay in traditional Medicare if that’s what they prefer, and would have traditional Medicare compete against private insurance companies for Medicare enrollees.

But it is completely inconsistent with Newt’s opposition to President Obama’s call for a so-called “public option” to compete with private insurance companies. In 2009, Newt told Good Morning America:

I guarantee you the language they draft for the public plan will give it huge advantages over the private sector or it won’t work…what they will do is rig the game…I mean, anybody who’s watched this Congress who believes that this Congress is going to design a fair, neutral playing field I think would be totally out of touch with reality.

Newt may not realize this, but he was actually explaining why his preferred Medicare reforms would fail: Congress would rig the game to protect the “public option” that Congress offers to seniors — i.e., traditional Medicare.  House Republicans, led by Paul Ryan, rather bravely stuck to their guns when they kept a “public option” out of their proposed Medicare reforms.  Ryan is offering Republicans credibility and success.  By his own admission, Newt is offering them failure.

What’s up with Mitt Romney and Newt Gingrich?  Does the Republican presidential nomination race have some sort of prize for insincerity or incoherence that I don’t know about?

Finally, Newt endorsed a “variation of the individual mandate” (tell me again why he opposes ObamaCare?) and said there is “a way to do it that make most libertarians relatively happy.” He must have meant to say leftists rather than libertarians. Regardless, I invite Newt to come to the Cato Institute so he can explain to people who actually care about freedom just how happy he’s going to make us.

Newt Tries to Out-Romney Romney, Endorses ‘Public Option’ in Medicare is a post from Cato @ Liberty - Cato Institute Blog

Handing tobacco regulation over to the FDA, as Congress is poised to do, is an epic public health mistake. It is tantamount to giving the keys of the regulatory store to the nation’s largest cigarette manufacturer, Philip Morris.

The legislation that will be voted on shortly in the Senate was cooked up out of public sight by Philip Morris, Sen. Ted Kennedy, Rep. Henry Waxman, and anti-tobacco lobbyists. Philip Morris staffers themselves even wrote large portions of the bill.

There are significant, and numerous, problems with the FDA regulating tobacco, and virtually no benefits to public health. Kennedy, Waxman, and the public health establishment present their legislation as a masterful regulatory stroke that will end tobacco marketing, prevent kids from starting to smoke, make cigarettes less enjoyable to smoke, and reduce adult smoking. But FDA regulation of tobacco will do none of these things.

The bill fails to correctly identify the reasons why young people begin to smoke, and concentrates almost exclusively on restricting tobacco marketing, while leaving the other risk factors for adolescent smoking unaddressed. There is nothing in the proposed legislation that shows the FDA understands the well-documented connections between education, poverty and smoking status, connections that provide the key to helping adults stop smoking.

FDA to Regulate Tobacco? Big Mistake is a post from Cato @ Liberty - Cato Institute Blog