Quote of the Day: "Bureaucracy is the death of all sound work." - Albert Einstein
Subject: Agency Madness
Here are three recent items with something in common . . .
#1: FDA experts have voted to ban the drugs Serevent and Foradil for asthma patients. The vote isn't binding, but the FDA generally follows such recommendations. And yet . . .
- One-third of these experts disagreed with banning these drugs for adult patients
- The leading rationale was that many patients used them incorrectly by not pairing them with a steroid. But what about patients who took the drugs responsibly and correctly?
- The total cost of these drugs plus steroids is still cheaper than that of two other asthma drugs, Advair and Symbicort, which were approved.
In other words, the panel voted to limit the clinical options of doctors and increase the costs for patients.
Even so, it could have been worse. Some FDA safety experts wanted to ban all four drugs because they may cause one death in "somewhere between 700 and 4,000 patients."
They apparently didn't listen to Dr. Richard Gower, President of the American College of Allergy, Asthma, and Immunology, who said, "We live in an imperfect world. All drugs have potential benefits and side effects."
#2: The FDA has also banned the use of chlorofluorocarbon (CFC) inhalers (MDIs) beginning this year. CFC products are believed to cause ozone depletion, and most of them were banned internationally by the Montreal Protocol of 1987. However,
- Medically essential products, such as CFC MDIs, have been exempt
- Medical products account for, at most, 0.5% of CFC consumption, meaning the ban is not environmentally necessary.
- Replacement inhalers (HFAs) are still patent-protected, and no generics can be made until 2010. HFA MDIs are 2-3 times the price of CFC MDIs, and require more diligence to clean and maintain. The poor, who are already more likely to suffer asthma, are paying a tax on their health for the sake of a symbolic environmental gesture.
- There is no medical justification for banning CFC MDI's.
- The same one-size-fits-all regulations will apply to both passenger airliners and non-commercial, business-owned jets that are used to move cargo and personnel. For instance, the "no-fly" list and Air Marshall provisions will apply to business planes even though the pilots usually know everyone on board personally.
- The definition of "large aircraft" is arbitrary, applying both to planes as small as 12,500 pounds and to 747's ten times that weight.
- Items that are prohibited in passenger jets will also be banned to employees in these smaller business planes, even if they are needed for their work. (Just think of what that will do to business efficiency in this time of recession.)
- Airplane owners will be forced to pay, at their own expense, for audits of their safety compliance. The audits won't even be done by government inspectors, but by private consultants.
- These rules can potentially expand to all aircraft and all airports.
The above three items are just a few examples of what federal regulatory agencies do to us, every day. They pass regulations and enforce policies that reduce our choices and increase our costs. While their actions often go unreported or are buried in newspapers, they profoundly affect large segments of our population and of our economy. Just ask asthma sufferers. Or the aviation industry.
All of this is done with little or no Congressional oversight. Instead, Congress passes general laws and expects regulatory agencies to "sweat the details." People have to obey agency dictates, even though they're created willy-nilly without any elected representation.
Downsize DC's Write the Laws Act (WTLA) will limit the authority of these agencies. Congress will be responsible for writing every law and regulation, using whatever expert advice they feel they need. But they must not delegate the rule-making power to others, they must sweat the details themselves.
Tell your Representative and your two Senators to introduce and pass DownsizeDC.org's Write the Laws Act. Cut and paste the three examples in this Dispatch into your personal comments. Use our quick and easy Educate the Powerful System to send your message.
Thank-you for being part of the growing Downsize DC Army.
Assistant to the President