TAKING ON BIG TOBACCO

Duties and Powers

100

This Government Agency was once described by the New York Times as "The most influential regulatory agency on earth."

What is the Food and Drug Administration.

200

This 1938 Congressional Act expanded FDA's regulatory reach.

What is the "Food, Drug and Cosmetic Act"

300

According to statute, the FDA had the power to regulate the following substances ______________ (name at least two).

What is (any of the following): most food, drugs, cosmetics, therapeutic devices, devices that emit radiation, animal feed and drugs, and the nation’s blood supply.

400

By the 1990s, the FDA employed ______ many employees, and had a budget of nearly _________ dollars.

What is 9,300 emploees and $900 million

500

DAILY DOUBLE (But still only worth 500 points because this internet template still sucks)

In your own words, explain to the class some of the pros and cons of SOCIAL REGULATION.

Kessler

100

This US President appointed David Kessler commissioner of the Food and Drug Administration

Who is George Herbert Walker Bush. (Kessler's appointment occurred in November 1990. Kessler was so successful in his post that president Clinton reappointed him, making him one of only two Bush appointees who made the Clinton cut.)

200

Kessler received his medical training from this prestigious American school.

What is Harvard Medical School. (Kessler also earned his law degree from the University of Chicago in 1978.)

300

Kessler worked part-time in the legislative branch for this Utah Senator

Who is Orrin Hatch. (Kessler once said to a reporter, "As a doctor I’m supposed to say that my most important training was my medical internship, but frankly, my years on Capital Hill were the most important. That’s what taught me how this town works.")

400

These were Kessler's two main priorities during his first year at the FDA

What is to "beef up the agency's power of enforcement" and "streamline the approval process of drugs and medical devices" (Kessler was successful on both of these fronts, hiring 100 criminal investigators in his first months at the FDA to work on enforcement and cutting drug approval times down from an average of 33 months to 17 months.)

500

As commissioner of FDA, Kessler declared a moratorium for several months on this specific substance, and then placed sharp restrictions on its use, leading Business Week to call him "Washington's most admired - and reviled - regulator"

What are silicone gel breast implants. (This specific act by Kessler proved to DC folks that he was a regulatory force to be reckoned with.)

Regulation of Tobacco

100

Until the 1990s, this substance had managed to elude classification as a drug or hazardous substance, and consequently the regulatory embrace of the federal government.

What is Tobacco. (Although this product had not been regulated by FDA, its use had been restricted by Congress on three occasions: 1) In 1965 when legislation required warning labels on cigarette packages; 2) In 1970 when cigarette advertising was banned on radio and tv; and 3) In 1990 when smoking was prohibited on airplanes.

200

One reason Congress had shown little appetite to place sharp curbs on tobacco products until the 1990s was because roughly _______ million Americans were considered smokers

What is between 45-50 million.

300

The Food, Drug and Cosmetic Act of 1938 had defined a drug in part as a substance "__________ to affect the structure of any function of the body."

What is a substance "INTENDED to affect the structure of any function of the body". (This use of the word "intended" would turn out to be the keystone of FDA's argument that it did indeed have authority to regulate big tobacco)

400

This is the main reason FDA maintained that it could not claim jurisdiction over tobacco prior to the 1990s.

What is big tobacco's claim that their product's were to provide "smoking pleasure" not "drug effects" to their customers.

500

This is/was one of the main casual arguments against FDA regulating big tobacco before the 1990s.

What is: it would lead to A TOTAL BAN of the product. (Or something like this: If the FDA were to assert jurisdiction over tobacco on the ground that it was a drug, it would effectively lead to a total ban on tobacco products—a logical consequence of the agency's obligation to ensure the safety and effectiveness of the drugs that came under its purview. In 1972 congressional hearings, then-Commissioner Charles Edwards drove home this point, warning that "if cigarettes would be classified as drugs, they would have to be removed from the market because it would be impossible to prove they were safe for their intended use.")

The Strategy (Tools and Tactics)

100

This tool is often used by governments to restrict behavior or actions by individuals that would directly threaten public health, or another individual’s safety, welfare, or well-being.

What is SOCIAL REGULATION.

200

This target population was the focus of FDA regulating strategy against big tobacco

What is the youth population (or children). (Kessler once called smoking a "pediatric disease" since addiction began at a young age.)

300

Offering regulators more flexibility and a variety of tools, FDA proposed regulating cigarettes as ______ delivery devices, instead of imposing an outright ban.

What is nicotine-delivery devices. (FDA found that nicotine could be regulated on the grounds that it was indeed a drug under the provisions of the Food, Drug and Cosmetic Act.)

400

____________ is just one of the many regulatory tactics FDA proposed taking to curb tobacco use.

What is: Banning cigarettes from vending machines, Prohibiting distribution of free samples, Limiting advertising that could reach children, Limiting promotional activities, Requiring manufacturers to “establish and maintain a national educational campaign in order to counter the pervasive imagery and reduce the appeal created by decades of pro-tobacco messages

500

_____________ is just one of the many challenges the FDA faced in implementing their rule.

What is: Congressional Turnover (Republican opposition) Lawsuits on the basis of jurisdictional and free speech grounds Questions about FDA's mission Questions about the appropriateness of FDA’s decision