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GENERIC IMPORT ANALYSIS REQUESTED BY WAXMAN IN PREPARING FOR DRUG EXPORT HEARING; LABELING OF DRUGS EXPORTED TO THIRD WORLD IS ALSO A CONCERN

Executive Summary

House Commerce/Health Subcmte. Chairman Waxman (D-Calif.) is asking the Pharmaceutical Mfrs. Assn. about the proportion of drug imports attributable to generic drug manufacture in preparation for an April 15 hearing on legislation to permit the export of drug products not approved by FDA. "What portion of all pharmaceutical products imported since 1980 are finished generic drug products, raw chemicals for generic drug products, inactive ingredients for generic drug products, or finished active ingredients for generic drug products?" the congressman asked in a March 17 letter to PMA President Mossinghoff. Waxman also inquired about the portion of pharmaceutical imports that constitute finished products, raw chemicals, inactive ingredients, or finished active ingredients for overall "drug products that were imported by U.S.-based companies with manufacturing and production facilities in the U.S." The question on generic imports is apparently aimed at breaking down the lump sum of growing import volumes to assess the balance of trade arguments for export changes. The question indicates that Waxman's staff may believe that the declining trade surplus for the U.S. drug industry derives from the importing of intermediates and generics. If generic products and ingredients are being imported in greater quantities in recent years, however, that information might add to the argument for incentives for manufacturing of new unapproved products in the U.S. for export. Waxman's letter to PMA and a similar questionnaire sent March 12 to FDA Com. Young contain a series of detailed queries concerning more than a dozen topics related to the legislation. The subcmte. chairman asked PMA to "describe the legislative proposal which the PMA used as the basis for its estimates of new exports and new jobs." Regarding the estimate for an increase in pharmaceutical exports, he asked: "What assumptions did the PMA use regarding (1) the type (re: antibiotics, analgesics, etc.) and (2) the commercial value (re: number of different drugs, their estimated price and estimated volume of annual sales) of the pharmaceuticals which would contribute to the increase." He also asked PMA to "indicate whether your methodology assumed that the production of any U.S. unapproved drugs, currently being manufactured outside the U.S., would be shifted to the U.S." Waxman also requested information on mislabeled drug products shipped to developing nations. "Does the PMA have any policy -- informal or otherwise -- regarding the failure of a member company to label a pharmaceutical product sold in a Third World country consistent with the indications, contraindications, and warnings required by its U.S. approval?" Waxman asked. He specifically requested information on "any instances" of unapproved indications added to and contraindications and warnings omitted from labeling for such products. The subcmte. has two bills before it: Waxman's Hazardous Drug Export Control Act (HR 3962) and a drug export bill introduced by two subcmte. members, Reps. Madigan (R-Ill.) and Scheuer (D-N.Y.). The latter measure (HR 3995) is essentially identical to the Senate bill which was introduced by Sens. Hatch (R-Utah) and Kennedy (D-Mass.) and is expected to be considered by the full Senate shortly after the Easter recess. Waxman asked FDA whether Good Manufacturing Practices for unapproved drugs would have the same significance as those for approved products. He also questioned whether FDA had the enforcement manpower to ensure that unapproved drugs would be shipped and labeled in accordance with the provisions of either HR 3962 or HR 3995. REP. WAXMAN's QUESTIONS FOR FDA ON DRUG EXPORT LEGISLATION The following questions are excerpted from a March 12 letter Rep. Waxman submitted to FDA Com. Young in preparation for an April 15 hearing on drug export legislation before Waxman's House Health Subcmte. FDA was asked to respond by April 7. GOOD MANUFACTURING PRACTICES -- Two of the pending bills (HR 3995 and S 1848) require the U.S. company importing an unapproved drug to manufacture, process, pack and hold the unapproved drug in accordance with "good manufacturing practices." Q -- What would "good manufacturing practices" mean for a drug that never has been approved by FDA and has no standards set by the United States Pharmacopeia? Q -- How do the "GMPs" for such a drug differ from "GMPs" for an approved drug? REQUIRED RESEARCH ACTIVITY TO EXPORT -- Two of the pending bills (HR 3995 and S 1848) require that certain unapproved drugs be the subject of some research activity before they can be exported. Unapproved drugs which are being sent to countries without an approval system or which and for "diseases (such as tropical diseases) or particular health conditions . . . which do not exist to a significant extent in the United States" must be the subject of a "current" IND, an NDA, or a "current drug master file containing all safety information required to be included in an (IND)." Q -- What does it mean for an IND to be "current"? What designation does FDA give an IND that is not current? Does FDA regularly monitor INDs to determine which are "current"? Q -- If a company submits an IND, but then carries out little or no activity under that IND, what action does FDA take? Does FDA regularly monitor INDs to determine whether companies are conducting activities under the authority of the IND? Q -- What is a "drug master file"? Does it contain only safety information, or efficacy data as well? What does it mean for a drug master file to be "current"? What designation does FDA give a drug master file that is not current? Does FDA regularly monitor drug master files to determine which are current? ENFORCEMENT Q -- How many full-time equivalent positions at FDA are currently assigned to determining whether (1) approved drugs that are exported are properly labeled at the time of export, and (2) unapproved antibiotics that are exported in conformity with the law? How many of these full-time equivalent positions are staffed by personnel who reside outside the U.S.? Q -- How many additional full-time equivalent positions would be required to assure that unapproved drugs exported under the provisions of HR 3995 are in conformance with law? Under the provisions of HR 3962? In each case how many full-time equivalent positions would have to reside outside the U.S.? SUCCESS OF HUMAN CLINICAL TESTING Q -- What percent of all INDs progress from Phase I to Phase II? What percent of all INDs for new chemical entities progress from Phase I to Phase II? Q -- What percent of all INDs progress from Phase II to Phase III? What percent of all INDs for new chemical entities progress from Phase II to Phase III? Q -- What percent of all INDs progress from Phase III to the filing of an NDA? What percent of all INDs for new chemical entities progress from Phase III to the filing of an NDA? Q -- What percent of all NDAs are approved? What percent of all NDAs for new chemical entities are approved? If FDA does not routinely monitor this information, use the period 1981-1985 in answering the questions.
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