Ms. Sally Katzen
Administrator
Office of Information
and Regulatory Affairs
Office of Management & Budget
Executive Office Building
Washington, D.C. 20503
Dear Ms. Katzen:
The Office of Advocacy has been in consultation with your staff concerning the draft final rule regulating the DEA exemption of pseudoephedrine-containing products. Although many of the concerns expressed in our initial comments to DEA on the proposed rule were addressed in the final proposal, we still have serious concerns regarding the proposed threshold requirements and the potential effects on competition in the marketplace.
The draft final rule was modified substantially to include the following changes/clarifications: 1) the threshold was raised from 24 grams to 48 grams, 2) the cumulative threshold requirement for multiple transactions of pseudoephedrine products in a calendar month won't apply to sales for personal use (hence, products will not have to be placed behind the counter nor records maintained for each transaction), 3) the registration requirement for retail distributors of regulated pseudoephedrine produces is waived, and 4) limited application of the rule to certain types of drugs (tablets, capsules and powder packets which do not contain therapeutically significant quantities of acetaminophen, aspirin or ibuprofen).
DEA's FAILURE TO DEMONSTRATE THE PROBLEM
The problem as defined by DEA is that illicit utilization of pseudoephedrine in clandestine laboratories is increasing and that the number of methamphetamine-related deaths is rising.(1) Since publication of the NPRM, DEA states that pseudoephedrine usage in seized laboratories increased from 22 percent to 28 percent. However, the source of the OTC product is not identified in relation to these percentages. Did the pseudoephedrine come from mail order, wholesale or retail establishments? What quantities were seized--perhaps the lab tech had a few boxes of Sudafed to treat his flu symptoms?
Of the eight anecdotal examples of alleged diversion at the retail level, only one cites definitive evidence of retail diversion. Some evidence of large quantities of pseudoephedrine being sold were documented, but no references are made to the end use of the product sold--save one example where retail receipts were discovered in a methamphetamine lab. Simply, insufficient evidence exists to require a training, reporting and recordkeeeping burden on the retail industry. There ought to be a greater nexus between the raided laboratories and the source of the methamphetamine.
FDA'S EPHEDRINE RULE
It seems peculiar that FDA made a similar attempt to place restrictions on an OTC drug (ephedrine-containing asthma products) with little or no evidence that the drugs labeled for their intended purpose were part of the problem of abuse cited in the proposed rule.(2) FDA cited instances of single-ingredient ephedrine products being marketed and used for purposes not approved by FDA (e.g. diet pills), and several instances of overdose by teens. However, no case was made for prohibiting the OTC availability of combination products approved for the treatment of asthma.
Government regulators must regulate only that behavior which is creating the problem. Overregulation serves no purpose other than to stunt the ability of small businesses to compete in the marketplace. Ultimately, overregulation may indirectly undermine consumer confidence, and raise the cost of perfectly safe and effective products at the cash register.(3)
The pattern of overregulation that emerges from the instant rule and the FDA rule is contrary to recent law and policy implemented during the Clinton Administration. The Small Business Regulatory Enforcement Fairness Act of 1996(4) calls upon agencies to modify their enforcement policies to accommodate small businesses. Similarly, a Spring 1995 directive issued to the heads of executive agencies by President Clinton urges each agency to eliminate unnecessary regulations.
ALTERNATIVES
Rather than assuming that retailers are eager to contribute to the methamphetamine problem in this country, why not assume that they would be willing participants in the war on drugs? DEA could promote a retailer awareness campaign alerting them to the problem of diversion and eliciting their help. There are probably many retailers who are unaware of the problem, yet willing to cooperate. For example, DEA could make available an 800 number for voluntary reporting of suspicious activity.
In the anecdotal evidence supplied by DEA, the pharmacist became suspicious in one instance and voluntarily contacted DEA investigators; and in another, when the pharmacist became aware that pseudoephedrine could be used to manufacture methamphetamine through a third party, she refused to place further orders for the customer.
In utilizing education as a tool rather than penalties, DEA's objectives may be achieved with far less cost. Those attempting to engage in diversion would be on alert that retailers will be looking for suspicious activity; and, retailers would not be in fear of retribution by government enforcers. The education campaign may also provide needed information to DEA regarding the scope of the problem, if any, in the retail industry.
CONCLUSION
There is absolutely nothing wrong with wanting to stem the tide of methamphetamine. Though a laudable goal, the proposed threshold requirements may actually do nothing to solve the problem, and may do a lot to destroy competition among businesses of differing sizes.
It occurs to the Office of Advocacy that perhaps DEA is not asking the right questions. In this instance, some appropriate questions might be: "Will a threshold requirement for the sale of OTC pseudoephedrine-containing products reduce the illegal manufacture of methamphetamine, or will some other less onerous method accomplish the same goal?" "Will fining innocent retailers or shutting down their businesses cause there to be any less methamphetamine on the street?" "Since there is only limited circumstantial evidence of diversion with respect to retailers, should we impose this type of burden on them?" When DEA defines the significance of the problem under the Domestic Chemical Diversion Control Act of 1993, they should look to the significance of the specific retail problem and not the general methamphetamine problem.
The Office of Advocacy urges DEA to reconsider the need for threshold requirements and target the industries that are proven to contribute to the problem of diversion -- mail order and wholesale establishments.
Sincerely,
Jere W. Glover
Chief Counsel for Advocacy
Shawne M. Carter
Assistant Chief Counsel for Advocacy
END NOTES
1. Draft final rule at p. 3.
2. See 60 Fed. Reg. 38,643 (July 27, 1995).
3. Theoretically, consumers could doubt the safety of the regulated drugs and avoid taking them for their allergy, cold and flu symptoms. Similarly, bulk packagers may reduce the size of their packaging in order to avoid potential liability. Smaller packages sizes mean higher prices per dose.
4. Pub. L. 104-121, signed March 29, 1996.