Tobacco Documents Online

tobacco p{::rE:¢P t0 ip~'i:;E~:`N R :~E ==P °0 IR PASSPORT TO ~CJP ( ) I~U I~ELi~Fr'-v North Carolina Congressman Burr says President rl ~ade wrong choice. By Colleen Zimmerman Blackard T he FDA is convinced it has legal authority over tobacco. North Carolina Congressman Richard Burr grimaces. "Cer- tainly the FDA feels like every govern- ment agency-that's one of the prob- lems we have." Burr is a freshman Congress- man representing the 5th district of North Carolina, a state whose tobacco industry provides more than 200,000 jobs and generates more than us$5.5 billion to those workers. The seat of the 5th dis- trict, incidentally, is Winston- Salem, home of R.J. Reynolds. Burr makes no apologies for his unabashed support of the tobacco industry. "Cynics may argue that my interest in the tobacco debate lies only in the parochial economics of my dis- trict and state," he has stated in a press release opposing President Clinton's anti-tobacco agenda. "While this may be true to a cer- tain extent, I cannot understand why the President believes a govern- ment bureaucracy is more effective than parents." Richard Burr bears an uncanny resemblance to former Vice President Dan Quayle-blondish hair, deep blue Congressman Richard Burr eyes, bright white smile. And he's among the wave of Republicans voted into office by constituents demanding government reform during last November's elections. His message, like those of other reform-minded Republicans: less bureaucracy, less big-government intervention, and a renewed emphasis on individual responsi- bility and choice. In his office on Capitol Hill, there are ashtrays. "Do you smoke?" "Yes," he says. "Me, too." We glance at each other, smile, and both grab our packs and light up. "It's the belief of the majority in Congress that FDA does not have jurisdiction," he says, blow- ing out smoke in a steady stream. "Congress decides-and has for- ever-the status of tobacco. We're not willing to relinquish that jurisdiction. "There's no question most Congressmen agree. RR 9n (tr.tnt or I QQ; I

"The FDA proposal litnits every tacet of the industry," Burr continues. "The President's proposed rule is an alarming statement; in his directive, he says that if a 50 percent reduction of teen smoking is not achieved in seven years, FDA is authorized to pro- mote further restrictions. THE FDA CLAIMS its review/approval time for new drugs and therapies is just over 19 months on average. Burr dismisses the statistic. "Their average is 14.8 years," he says. "They can't even live within the framework set out for them." But the FDA says review/approval is completed in mere rnorrtlu. "There's never been anyone who held federal agencies accountable for their words," Burr replies. Just then he pulls out a round piece of white plastic. It's flat, like a pancake, and between the plastic lay- ers is slippery silicon. "This was designed for home breast exams, for lumps. It was designed to replace soap and water. The inventor of this won an Inventor of the Year Award in 1985. "He applied to the FDA. FDA picked up his inventory, because this was considered a medical device. The application/rejection phase is sup- posed to be 90 days. Two months ago, this company filed for bankruptcy. And this product is yet to be approved. Remember, FDA approval began 10 years ago. "We need to reform what FDA cur- rently does, not attempt to expand its jurisdiction." Burr pauses. "I think this is Kessler's attempt to expand the FDA budget. Since 1970, the FDA applica- tion time has doubled, the number of employees has doubled and the bud- get has doubled. "We [in Congress] are going to look at FDA reform," he says. "Maybe by the time courts decide [on FDA authority over tobacco], the FDA of the future will look nothing like the FDA of today." "THE ULTIMATE QUESTION is, did the President make the right choice?" Burr asks. "The President had two choices: a partnership among the industry, Congress and parents to create a vol- untarv list of actions that will reduce vouth smoking, or choose to turn over the matter to FDA as a government initiative. By choosing FDA, he not oniv chose to delay implementation a few years (because the question of authority will be tied up in court), but he completely cut out of the process members of Congress, parents of kids in America, and an inca.r,trv %% illing to spend money in t<: education ring, which is wher:• .•, tv will, in fact, reduce teen tobacco u,a~,Te. The President's decision was flawed." What happens next? "I think you'll see Congress slow to suggest legislation," Burr predicts, "because of the President's decision to let courts make the decision. "There's no need for Congress to do anything," he says, stubbing out his smoke. "I feel confident the courts will uphold the tobacco industry's belief that the FDA has no jurisdiction over tobacco." ~,°eoccupied J ames Phillips was Dr. Kessler's special assistant for investiga- tions for three years at the U.S. Food and Drug Administration. At the end of his term, a frustrated Phillips fired off a le%:±er to U.S. Representative Alan Sloi,oclin, expressing his dismay over Kessler's priorities. The letter originally appeared in Food and Dn{g Irtsido Report. July 14, 1995 Dear Mr. Slobodin: There is no justification for the level of FDA resources that has gone into Dr. Kessler's cigarette initiative over the last year and a half. As you may know, I served for a three-year period (August 1991 July 1994) as Dr. Kessler's special assis- tant for investigations. Until the cig- arette investigation began, I had ready access to Dr. Kessler, and my office worked on most of the major projects before the agency. We played a key role, for instance, in the 1993 investigation that led to a consent agreement with the American Red Cross to improve its management of the nation's blood supply. In the months since the blood investigation, Dr. Kessler and his top aides have spent the vast majority of their time on the ciga- rette project. For the better part of the spring of 1994, Dr. Kessler spent virtually all of his time on cigarettes. I can recall several instances in which I tried to contact Dr. Kessler on important matters and was told by his secretary that if my topic was anything other than cigarettes, the Commissioner would not have time for me. I can't comprehend how Dr. Kessler will find resources to enforce any tobacco restrictions when he doesn't have enough field investiga- tors at present to properly inspect foreign drug products entering this country. Other pressing needs that were ignored because of FDA's preoccupa- tion with tobacco were abuses in drug compounding by pharmacists, re-analysis of dose levels and label- ing of pre-Food and Drug Act pre- scription drugs, completion of report on the safety and efficacy of the drug Halcion, failures to proper- ly inspect methadone clinics, gross misuse of travel funds, and a need to separate the product approval and enforcement functions of FDA as was done some time ago with the Atomic Energy Commission. FDA is an important agency. As I told Ms. Suydam in 1994, FDA has some great infantry down in the trenches. The competence and dedi- cation of the "grunts" in FDA is unfortunately not matched by the level of generalship at FDA head- quarters. That generalship is turfy; arrogant, bored and hostile to inno- vation. Some accountability and dis- cipline needs to be established. A vigorous round of oversight hear- ings could do just that. Sincerely, James G. Phillips October 1995 'rR 39