Tag Archives: fda

CEI Podcast for February 16, 2012: Washington’s Prescription Drug Shortage


Have a listen here.

Patients are suffering from a nationwide shortage of more than 260 different prescription drugs, many of them for different types of cancer. Senior Fellow Greg Conko explains why the biggest culprit for the drug shortage is Washington. DEA and FDA regulations make it difficult to ramp up supply, or to change prices to more accurately reflect demand.

CEI Podcast for February 2, 2012: The FDA’s Latest Power Grab

Have a listen here.

Fellow in Consumer Policy Studies Michelle Minton breaks down the FDA’s behind-the-scenes push to regulate dietary supplements nearly as strictly as prescription drugs.

No Such Thing as an Average Cancer Patient

My colleague Greg Conko has an excellent piece in today’s Wall Street Journal. Greg doesn’t think it’s right that the FDA is denying terminally ill patients access to potentially life-saving treatments.

The latest case in point is a drug called Avastin. It is approved for treating several types of cancer. But the FDA is moving to revoke its approval for treating breast cancer. This has, understandably, upset many breast cancer patients and their doctors.

The heart of the matter is who shall be in charge of treatment decisions. Should it be patients and doctors? Or should the FDA decide for them?

Greg thinks a decentralized approach is better. Different patients will react to the same drug in different ways. A doctor can see if Avastin works or not for a patient, and they can make the right decision from there. The FDA relies on averages and medians for making its approval decisions, ignoring individuals. The trouble with that is, as Greg points out, there is no such thing as an average cancer patient.

A few weeks ago, I interviewed Greg about Avastin and the FDA here.

CEI Podcast for May 31, 2011: FDA Rescinds Approval of Breast Cancer Drug

 

Have a listen here.

Senior Fellow Greg Conko breaks down the fight over Avastin, a drug used to treat several types of cancer. The FDA is poised to rescind Avastin’s approval for treating breast cancer. It will retain its approval for other cancers. This will make life difficult, and possibly shorter, for some breast cancer patients. Conko believes this battle boils down to one question: who decides which treatments patients can use? Will it be the FDA, or doctors and patients?

Regulation of the Day 170: Kinder Eggs

Kinder eggs are a type of candy that enjoys worldwide popularity. They are chocolate eggs with a plastic shell underneath the outside layer of chocolate. After kids enjoy the chocolate, they can open up the plastic shell and find a toy inside. They are especially popular around Easter.

They are also illegal in the United States. The Consumer Product Safety Commission and the Food and Drug Administration have declared the toys to be a safety hazard. Children could choke on them.

A third agency, Customs and Border Patrol, confiscates about 25,000 kinder eggs per year. Most people know that kinder eggs aren’t actually a choking hazard, so they don’t know about the ban and think nothing of bringing some home from a trip.

NRO’s Mark Steyn recently had just such a run-in when he and his children returned from a trip to Canada:

My kids asked the CBP seizure squad if they could eat the chocolate in front of the border guards while the border guards held on to the toys to prevent any choking hazard — and then, having safely consumed the chocolate, take the toys home as a separate item. This request was denied.

As I noted in a previous Regulation of the Day:

According to WebMD, 66 to 77 children under 10 die every year from choking on food in the U.S. That’s out of more than 42,000,000 children under 10, according to my calculations from U.S. Census data.

That means your child’s odds of choking to death on food are about 1 in 545,000. And that’s assuming 77 deaths, the high end of the range. Little Timmy is literally more likely to be struck by lightning (1 in 500,000) than choke to death on a hot dog.

I’m sure that CPSC, FDA, and CBP would love to credit their diligence in enforcing the kinder egg ban for those reassuring numbers. But common sense says they shouldn’t.

CEI Podcast – November 30, 2010: Food Safety, Washington-Style

Have a listen here.

CEI Senior Fellow Greg Conko looks at the major provisions of the food safety bill that the Senate is voting on today. The bill would set in stone ever-evolving best practices. Changes to plant inspection and food recall policies are a mix of ineffectiveness and perverse incentives that could raise food prices. Overall, the FDA is too blunt an instrument to be effective on this sensitive issue.

Regulation of the Day 123: Donating Blood

If you’re gay, you can’t donate blood. It’s illegal. The ban was put in place in 1983, during the early days of the HIV/AIDS scare. It may have made some sense in those days, when HIV testing was less than trustworthy. But it sure doesn’t now, with modern screening technology.

Obviously, keeping HIV-positive blood out of circulation is a wise policy goal. But most gay people don’t have HIV/AIDS. Rather than screening donors for sexual preference, they should be screened for blood-borne diseases. Straight people already are. And it works quite well. Current policies are keeping healthy, willing donors out of the system.

The outdated ban could soon be coming to an end. Sen. John Kerry and 15 of his colleagues, usually more prone to passing regulations than repealing them, are urging the FDA to repeal this one. You can read their letter here.

The one disconcerting thing about the letter is that every single one of the signees is Democratic. Not one Republican joined in. That could be because Sen. Kerry and the others deliberately excluded them for political reasons. But the GOP is famously behind the curve on gay rights issues. So maybe Republicans were asked, and said no. I don’t know.

Republicans should send their own letter supporting Sen. Kerry’s position. Enlarging the pool of eligible blood donors is an unabashed good. It’s a classic gay rights issue. It’s also a health issue. Blood would be more readily available for patients who need it. Economists would add that increasing the supply of blood will lower its price – a good thing in this age of rapidly rising health care costs.

Regulation of the Day 98: Gastrointestinal Drugs

Did you know that the federal government has a Gastrointestinal Drugs Advisory Committee? It’s true. If you don’t believe me, you can attend their upcoming meeting on February 23. The topic of the day will be a new drug application to treat hepatic encephalopathy.

Hopefully some hepatic encephalopathy sufferers will be there. They can ask the Committee why the FDA takes as long as a decade (and as much as $800 million!) to approve medications that could be helping people and saving lives right now.

Regulation of the Day 76: Generic Medication for Farm Animals

If you put chlortetracycline powder in your farm animals’ drinking water to prevent disease, please be aware that a new federal rule now allows you to buy a generic version of the powder if you wish.

Actually, I probably shouldn’t be calling that rule a “rule.” As the new rule states:

This rule does not meet the definition of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because it is a rule of ‘‘particular applicability.’’

Despite the rule being called a rule twice in one sentence, it really isn’t a rule. Probably best to let logicians sort that one out.

Oyster Ban Update: Partial Victory!

Remember the raw oyster ban from a recent Regulation of the Day? I am happy to report a partial victory (hat tip to Jacob Grier).

The ban, due to take effect in 2011, has not been repealed outright. But, in response to public outcry, it has been delayed:

The FDA announced it would commission a study to explore alternatives to reducing the illness vibrio vulnificus, and also do an economic analysis of how the ban would impact the oyster industry.

“Before proceeding, we will conduct an independent study to assess how post-harvest processing or other equivalent controls can be feasibly implemented in the Gulf Coast in the fastest, safest and most economical way,” according to an FDA news release.