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FDA Archive

Wednesday

3

August 2011

0

COMMENTS

Eight Anti-Science Senators Seek to Halt GE Salmon

Written by , Posted in Energy and the Environment, Government Meddling

For eight years we listened to self-righteous lefties wrap their personal policy preferences under the cloak of objective science, then beat  anyone who disagreed with those preferences over the head with charges of being “anti-science.” So when will we see the same treatment for the 7 Democratic Senators + 1 liberal Republican Lisa Murkowski for their letter threatening the FDA if they do not override the science in favor of their political opposition to genetically engineered salmon?

A group of senators has asked the Food and Drug Administration to abandon its approval process of genetically engineered salmon as food, threatening to push legislation to strip the FDA’s funding to study the fish if the agency does not comply.

Eight senators sent a letter dated July 15 to the FDA asking it to “immediately cease” consideration of such salmon, a product brought before the agency by AquaBounty Technologies 15 years ago.

…Although the fish would be kept in a land-based facility, environmental groups worry that the salmon could escape and potentially harm fish in the sea. They’re also concerned that the fish, which do not get any larger than unmodified salmon but grow twice as fast, could out-compete native populations for food.

…The senators, who represent coastal states with thriving fisheries such as Alaska, Oregon and Washington, pledged not to provide funding for the program should the FDA go forward with the approval process. They argue that genetically modified salmon could kill jobs by interfering with the fish farming industry, cause environmental damage and potentially harm consumers.

“I just don’t see a reason from a fundamental standpoint why we have to start manufacturing ‘Frankenfish’ when we have incredible fisheries that employ thousands of people,” said Sen. Mark Begich (D-Alaska).

And here we see their true motives. They are seeking to abuse the purpose of the FDA in order to protect existing industries in their states from competition. They threw out some token scientific concerns, but they are clearly flimsy.

“Even if someone were to steal and release them into the ocean of Panama, they would have to swim thousands of miles to find mates,” said Bill Muir, a professor of animal sciences at Purdue University who specializes in genetics and environmental risk assessment, particularly of fish. Muir said he’s looked at AquaBounty’s product and deemed it safe for the environment.

Their real concerns are based on protectionists economics and narrow self interest, as they seek to protect potential donors and supporters in their respective states. In other words, they are putting their political interests ahead of what’s right. This should come as no surprise, as the political system is designed to encourage just such behavior. This is one of the many faults with creating organizations such as the FDA in the first place. They are inherently part of the political process, and subjective to all the negatives of the incentive structure associated with it. Even if this attempted bullying does not succeed on this particular issue, it will and has already on many others.

Friday

1

July 2011

2

COMMENTS

FDA Stifles Innovation

Written by , Posted in Big Government, The Nanny State & A Regulated Society

Michael Mandel at the Progressive Policy Institute has recently published a paper called “How the FDA Impedes Innovation: A Case Study in Overregulation.” Before getting into the paper, I want to point out that  this is a good illustration of just how far left the current Democratic party has moved. The PPI is affiliated with the Democratic Leadership Council, that group of “New Democrats” which at one time held considerable clout (President Clinton was a member), and believed the Democratic Party should move away from the leftism of the 60’s era party. Last I heard the DLC had dissolved, their politicians replaced by hard-left ideologue Democrats like Barack Obama who would never in their wildest dreams consider such as thing as “overregulation” even possible. If a Republican or conservative group pushed a paper like this, they’d be demagogued by the current Democratic party as wanting to kill people with tainted food, or some such nonsense.

But let’s get to the topic at hand: the Food and Drug Administration. The FDA, an organization I’ve picked on a good bit already, is probably one of the more destructive government agencies in existence. It has a perverse incentive structure (if bad drugs are approved then heads roll, if good ones are denied then no one notices) that guarantees that many good, life-saving drugs take extra long to make it to market, or might not at all. It also suppresses innovation by raising costs of development. But it’s not just drugs that suffer the burdens of the FDA. As the paper demonstrates (Hat-tip: Marginal Revolution), other medical innovations are kept from the market, harming us all.

I … show how the FDA is clearly applying “too-high” standards in the case of one noninvasive device currently under consideration—MelaFind, a handheld computer vision system intended to help dermatologists decide which suspicious skin lesions should be biopsied for potential melanoma, a lifethreatening skin cancer.

If we look back at the economic history of the past 200 years, one pattern stands out clearly—new technologies start out expensive, but then end up cutting costs over time. For example, gasoline-driven tractors were initially much costlier and less reliable than horses. Over time, however, tractors were improved and made much less expensive, and the resulting shift to mechanized agriculture helped drive down the cost of producing food.

Similarly, when cell phones were first introduced in the 1980s, they were bulky, heavy devices which retailed for $4000, provided terrible reception and could barely fit in a briefcase, much less a pocket. After 20 years of  evolution, iPhones and Android smartphones are slender, light, relatively cheap and far more capable than their ancestors.

…Three facts are clear. First, the FDA’s regulatory reach and intensity has increased over the past 10 years. FDA employment grew by 33 percent between 2000 and 2011, even as employment in the regulated industries—pharmaceuticals, medical devices, and biotech–only rose by 3 percent.

Second, in the wake of high-profile episodes such as the Vioxx case, the FDA has gotten stricter about requiring evidence of safety and effectiveness before approving new  drugs. Third, the number of new drugs approved fell sharply over the past decade compared to the decade before.

…[T]here is one ongoing example that suggests the FDA might have crossed the line into over-regulating and suppressing innovation. This is the case of MelaFind, which as noted above, is a handheld computer vision device intended to help dermatologists decide which suspicious skin lesions should be biopsied for potential melanoma. The device is pointed at a lesion, the visual image is rapidly compared to a computerized database, and the results are reported to the doctor.

A device such as MelaFind, if approved, could be a very useful tool, since melanoma is easy and cheap to treat when caught early, and expensive and difficult to treat if detection is delayed. MelaFind would provide an immediate second opinion for dermatologists, and a dermatologist working long hours in an inner city or rural clinic could use MelaFind’s expert system to provide consistent advice. This availability of this tool is especially important as cost pressures force doctors to spend less time with each patient.

In order to get approval, Mela Sciences, the company that created MelaFind, did a multi-year study of the accuracy of the device compared to a panel of dermatologists. The company claims that it passed the test that the FDA had agreed to.2 Indeed, on some dimensions of the study the device did better than the panel of dermatologists.

Nevertheless, the FDA staff deemed the device “not approvable,” saying that MelaFind “puts the health of the public at risk.”3 Despite the strong negative response from the FDA, the company requested that the device be assessed by a panel of dermatologists, statisticians, and other medical experts. The advisory panel met in November 2010 and voted narrowly to recommend approving MelaFind.4 Nevertheless, the FDA has not yet approved the device.

The FDA rationale is incredibly weak. They claim the device did not do better than the experienced dermatologists, that it did not find every melanoma in the sample, and that it did not make inexperienced dermatologists the equal of experienced dermatologists.

Let me be clear: these are profoundly stupid criteria. As the paper did a good job illustrating, technology develops rapidly after introduction. That it is presently not better than, but is no worse than, existing dermatologists is not a reason to prevent technology from entering the market, where it can continue to get better and more efficient. Or as the paper said:

To summarize, the FDA seems to be saying that it cannot approve MelaFind unless the device can:

  • Outperform experienced dermatologists
  • Perform well on any lesion that an inexperienced doctor might find suspicious
  • Never miss any melanomas
  • Turn an inexperienced doctor into the equivalent of a board-certified dermatologist.

This is a standard that no first-generation device can ever reach. If the FDA fails to approve MelaFind, it would be the equivalent of rejecting the first cell phone on the grounds that callers might mishear important messages.

This is a prime example of how big government stifles innovation and reduces well-being.

 

Saturday

30

April 2011

0

COMMENTS

Courts and FDA Interpret Mandate to Regulate Tobacco as Authority to Regulate Non-Tobacco E-Cigarettes

Written by , Posted in The Courts, Criminal Justice & Tort, The Nanny State & A Regulated Society

First the nanny’s attempted to gain control over e-cigarette’s by labeling them as a drug. They got shot down in court, and have now given up that approach. Instead, with the courts blessing, they’ve moved onto the more absurd angle that the tobacco-less products can be regulated as tobacco product:

The Food and Drug Administration said Monday it plans to regulate electronic cigarettes as tobacco products rather than continue trying to classify them as a combined drug and medical device. The agency said it will soon be issuing a proposed rule on e-cigarettes.

Electronic cigarettes vaporize tobacco, along with a chemical compound that includes nicotine, without producing smoke. The government has said the chemicals in e-cigarettes are untested and potentially harmful.

The article above from The Hill is incorrect. E-cigarettes do not “vaporize tobacco,” but rather a nicotine bearing liquid solution.

In some ways this is actually a victory for freedom, as the FDA originally sought to regulate e-cigarette’s under its much more onerous regime on medical devices. It was the court that originally concluded that e-cigarettes are tobacco products (under the reasoning that nicotine is derived from tobacco), and thus subject to regulation under the Family Smoking Prevention and Tobacco Control Act. This prevents the FDA from banning the product as an unapproved pharmaceutical, but still gives it significant authority to ban it through other means.

There is no argument that e-cigarettes can potentially harm anyone but the user, if they are shown even to do that. Thus, in a free society where individuals are able to choose what risk they wish to take, there should be zero impetus for government regulation. But this is a nanny state, where your choices are subject to pre-approval by busybodies who know what is best for you.

Saturday

12

March 2011

0

COMMENTS

$10 + Government Meddling = $1,500

Written by , Posted in Free Markets, Government Meddling, Health Care, Welfare & Entitlements, The Nanny State & A Regulated Society

And not in the good way.

A drug for high-risk pregnant women has cost about $10 to $20 per injection. Next week, the price shoots up to $1,500 a dose, meaning the total cost during a pregnancy could be as much as $30,000.

That’s because the drug, a form of progesterone given as a weekly shot, has been made cheaply for years, mixed in special pharmacies that custom-compound treatments that are not federally approved.

But recently, KV Pharmaceutical of suburban St.Louis won government approval to exclusively sell the drug, known as Makena (Mah-KEE’-Nah). The March of Dimes and many obstetricians supported that because it means quality will be more consistent and it will be easier to get.

None of them anticipated the dramatic price hike, though…

Of course they didn’t, because they don’t think about the consequences for their feel-good meddling.

Makena is a synthetic form of the hormone progesterone that first came on the market more than 50 years ago to treat other problems. Hormone drugs came under fire in the 1970s, following reports they might damage fetuses in early pregnancy. In the 1990s, the early incarnation of Makena was withdrawn from the market.

But the drug got a new life in 2003, with publication of a study that reported it helped prevent early births to women who had a history of spontaneous preterm deliveries.

…The study of women at risk for this condition found that only about 36 percent of those given the progesterone drug had preterm births, compared with 55 percent among those not on the drug.

…To get FDA approval, the company is spending hundreds of millions of dollars in additional research, including an international study involving 1,700 women, Divis said. The FDA last month signed off and gave Makena orphan drug status. That designation ensures Ther-Rx will be the sole source of the drug for seven years.

I’d say that the fools got what they deserve for wanting their precious “FDA approved” in front of what was already a perfectly good and safe drug, but really it’s the rest of us that will bear the costs through increased insurance premiums and entitlement subsidies, or loss of access to a beneficial drug.

It just amazes me that the doctors in the article, who are presumably intelligent people, are shocked and surprised that adding an expensive approval process and a government granted monopoly would make something more expense.

How can we ever hope to create good public policy with so much economic illiteracy to contend with?

Tuesday

25

January 2011

0

COMMENTS

More Government is not the Answer for Too Much Government

Written by , Posted in Big Government, Free Markets, The Nanny State & A Regulated Society

Once again confirming that this administration believes that more government is the first, best and only solution to any problem, Obama is proposing billions of dollars in new spending on an activity that ought to be left to the private sphere:

The Obama administration has become so concerned about the slowing pace of new drugs coming out of the pharmaceutical industry that officials have decided to start a billion-dollar government drug development center to help create medicines.

The new effort comes as many large drug makers, unable to find enough new drugs, are paring back research. Promising discoveries in illnesses like depression and Parkinson’s that once would have led to clinical trials are instead going unexplored because companies have neither the will nor the resources to undertake the effort.

The initial financing of the government’s new drug center is relatively small compared with the $45.8 billion that the industry estimates it invested in research in 2009. The cost of bringing a single drug to market can exceed $1 billion, according to some estimates, and drug companies have typically spent twice as much on marketing as on research, a business model that is increasingly suspect.

This is typically unquestioning coverage by the New York Times, as the article never once addresses alternatives to the government’s assumption that private drug makers just aren’t investing enough. Take this sentence, for instance: “The new effort comes as many large drug makers, unable to find enough new drugs, are paring back research.” Now read it with this additional clause I’ve added: “The new effort comes as many large drug makers, unable to find enough new drugs to pay for the costs of investing in research, are paring back research.”

This addition is both accurate and clarifying, and it makes apparent a question both the administration and the New York Times fails utterly to address. Just why is it so expensive to develop drugs that many companies are concluding that it’s not worth as much effort as we might like? The reason neither wants to ask the question is because they know the answer: it’s because of too much government.

(more…)

Tuesday

20

April 2010

0

COMMENTS

They Can Pry The Salt Shaker From My Cold, Dead Hands

Written by , Posted in Health Care, Welfare & Entitlements, The Nanny State & A Regulated Society

The nannies have set their sights on another target: salt.

The Food and Drug Administration is planning an unprecedented effort to gradually reduce the salt consumed each day by Americans, saying that less sodium in everything from soup to nuts would prevent thousands of deaths from hypertension and heart disease. The initiative, to be launched this year, would eventually lead to the first legal limits on the amount of salt allowed in food products.

…Officials have not determined the salt limits. In a complicated undertaking, the FDA would analyze the salt in spaghetti sauces, breads and thousands of other products that make up the $600 billion food and beverage market, sources said. Working with food manufacturers, the government would set limits for salt in these categories, designed to gradually ratchet down sodium consumption. The changes would be calibrated so that consumers barely notice the modification.

The legal limits would be open to public comment, but administration officials do not think they need additional authority from Congress.

Not only has the conventional wisdom on salt flip-flopped repeatedly over the decades, but even the most recent research is entirely ambiguous.

It’s also disturbing that the FDA thinks they can do this without additional Congressional authority.  It’s even more disturbing in that they may be right according to modern Constitutional understanding.

Remember, Obamacare has only given them more excuse to regulate your choices regarding anything that might plausibly be said to affect your health.

Friday

12

June 2009

2

COMMENTS

Government Conquers Tobacco Industry

Written by , Posted in Legislation, The Nanny State & A Regulated Society

Another industry has fallen to the government onslaught.  With passage of H.R. 1256, of Family Smoking Prevention and Tobacco Control Act, the FDA has assumed oversight control of the tobacco industry with a broad mandate to set rules on advertising, warning labels and product ingredients.  They even have the “power to set standards that could reduce nicotine content and regulate chemicals in cigarette smoke.”  The only thing they can’t do is flat out ban cigarettes or the use of nicotine.

The name of the bill almost gets it right.  This is about control, but of you, not of tobacco.  This is about the government’s conclusion that the decisions made by free people like you are not the correct decisions you should be making.  The nannies in Congress think they know better than you what is good for you.  Clifford E. Douglas of the University of Michigan’s Tobacco Research Network labeled the bill “a historic step changing the nature of tobacco in society forever.” Changing the nature of anything in society necessarily involves changing the behaviors of individuals in society.  The proper way to do this in a free society is through persuasion, but anti-tobacco crusaders have always preferred force.  The bill even includes a mandated study on the “public health impact” of raising the minimum age to purchase tobacco products, once again proving that even in America, being an adult isn’t always enough to guarantee freedom of choice.

The added control for the anti-smoking forces in Washington also places the government in the awkward position of discouraging smoking, while at the same time being utterly dependent on the revenues generated by their “sin taxes” on tobacco.  This gives government a perverse incentive to reduce product potency, under the guise of public health concerns, and force consumers to purchase more cigarettes (and thus pay more taxes) to get the same “fix.”  And just to kick tobacco firms while they are down, the FDA will assess a “fee” on them for the pleasure of having their decisions controlled by the government.

Monday

27

April 2009

0

COMMENTS

Superfluous Government Agencies Can Never Be Understaffed

Written by , Posted in The Nanny State & A Regulated Society

MSNBC is fretting that the FDA is understaffed:

The FDA is responsible for overseeing the safety of the nation’s foods, drugs, medical devices and consumer products. In each of those areas, the agency is widely regarded as having fallen down on the job.

But its biggest black eye comes from the way the agency has handled its food safety responsibilities.

This is a common refrain from nanny-staters.  If only they had more money.  If only they had more people.  If only they had more regulations.  If only they had more government!  The President himself echoed this line, lamenting that, “at a bare minimum, we should be able to count on our government keeping our kids safe when they eat peanut butter.”  What a sad commentary on his view of American government.  Mr. President, making government responsible for protecting everyone from everything, even down to their peanut butter, cannot reasonably be considered a “bare minimum.”  It’s also not possible.

The President is using the recent episode of contaminated peanut butter to scare people into supporting ever more government.  This is not surprising, as fear is the typical driver of government expansion.  Stoking fear allows the nanny-staters to avoid explaining just why they believe government regulators can accomplish that tiny little task of “keeping [all] our kids safe when they eat peanut butter.”

If there is a government regulatory agency that has ever accomplished the goal of eliminating the danger or risk it was conjured to protect us from, I’ve yet to hear of it.  Government agencies, and the bureaucrats that run them, simply do not have the incentives necessary to compel efficacy.  Instead, government creations inevitably get co-opted by industry leaders, which then utilize the unique power of government force to protect not the consumer, but themselves – from market competition.

Thankfully, effective government is not necessary in situations like this.  Food suppliers have ample incentive to ensure the quality of their product. Poisoning one’s customers is a fast path to bankruptcy.  This is not to say that mistakes will never be made, as they are inevitable.  Private companies that make mistakes pay a high price, as Peanut Corp. of America learned when it filled chapter 7 bankruptcy after poor sanitary conditions at several of its plants lead to an outbreak of salmonella.  This is contrasted with the bigger budgets and greater powers that usually come after government screw ups.  Which incentive structure makes you feel safer?

Furthermore, the presence of government inspectors makes both consumers and producers lazy.  Suppliers rely on government to prove the safety of their products, rather than having to go the extra mile to convince customers themselves, while consumers with unjustified faith in government do less research and investigation of companies and products than they otherwise would.  When this combination of government and consumer apathy inevitably results in lapses, the immediate call is always to exacerbate the situation by giving government more responsibilities, and the individual less.  It’s a cycle of dependence that must be broken, and we can start by acknowledging that not only is the FDA not understaffed, but that even a single staffer is one too many.

Wednesday

4

March 2009

0

COMMENTS

Here Comes The Nanny State After Your Cigarettes

Written by , Posted in Free Markets, The Nanny State & A Regulated Society

They’ve been after them for years.  Nanny state do-gooders hate the idea that people can make their own choices about what risks to take.  Their latest freedom restricting plan?  Give the incompetent FDA control over the tobacco market.

In what appears to be the best chance since public health groups started pushing for it in the 1970s, Congress is poised to regulate tobacco, a product linked to 1,200 deaths each day but sold largely unfettered for centuries.

Legislation that the House Energy and Commerce Committee will take up today would place tobacco under the control of the Food and Drug Administration. Among other things, the bill would restrict the ways tobacco companies market cigarettes, require them to disclose the ingredients in their products and place larger warning labels on packages, and give the FDA the authority to require the removal of harmful chemicals and additives from cigarettes.

In what bizarro world has the Washington Post been living in that makes them think tobacco has been sold “largely unfettered?”  It truly boggles the mind.

About Me

profileI serve as Vice President of the Center for Freedom and Prosperity, a non-profit think tank dedicated to preserving tax competition and free markets. This site features my personal views, which are not reflective of CF&P.

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