B-150387, JUL. 9, 1963

B-150387: Jul 9, 1963

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INC: REFERENCE IS MADE TO YOUR LETTER DATED JUNE 17. THE BASIS FOR YOUR PROTEST WAS. THAT YOUR SUPPLIERS HAVE SATISFIED THE FOOD AND DRUG ADMINISTRATION WITH REGARD TO THE PURITY OF THEIR PRODUCT. THAT THE CLINICAL DATA SUBMITTED TO THE FOOD AND DRUG ADMINISTRATION SHOWED THAT THE RESULTS OBTAINED BY THE USE OF "ORINASE" TABLETS AND YOUR PRODUCT WERE THE SAME. YOU INSISTED THAT YOUR PRODUCT IS EQUALLY AS EFFECTIVE AS THE LATTER. YOUR NEW DRUG APPLICATION WAS MADE CONDITIONALLY EFFECTIVE BY THE FOOD AND DRUG ADMINISTRATION. FOR THE REASONS SET FORTH IN YOUR LETTER YOU REQUESTED THAT OUR OFFICE RENDER A DECISION WHICH WILL ENABLE YOU TO PARTICIPATE IN THE FUTURE PROCUREMENT OF TOLBUTAMIDE TABLETS BY THE DEFENSE MEDICAL SUPPLY CENTER.

B-150387, JUL. 9, 1963

TO PREMO PHARMACEUTICAL LABORATORIES, INC:

REFERENCE IS MADE TO YOUR LETTER DATED JUNE 17, 1963, AND TO PREVIOUS CORRESPONDENCE, RELATIVE TO YOUR PROTEST AGAINST THE CANCELLATION BY THE DEFENSE MEDICAL SUPPLY CENTER, DEFENSE SUPPLY AGENCY, BROOKLYN, NEW YORK, OF REQUEST FOR QUOTATIONS NO. DSA-2-1918, ISSUED UNDER DATE OF NOVEMBER 1, 1962, COVERING THE PROCUREMENT OF A QUANTITY OF TOLBUTAMIDE TABLETS.

THE BASIS FOR YOUR PROTEST WAS, FOR THE MOST PART, SUMMARIZED IN YOUR LETTER OF APRIL 23, 1963, WHEREIN YOU ALLEGED THAT THE TOLBUTAMIDE TABLETS PROPOSED TO BE FURNISHED BY YOU MEET ALL OF THE SPECIFICATIONS OF THE UNITED STATES PHARMACOPEIA; THAT YOUR SUPPLIERS HAVE SATISFIED THE FOOD AND DRUG ADMINISTRATION WITH REGARD TO THE PURITY OF THEIR PRODUCT; THAT THE FOOD AND DRUG ADMINISTRATION HAS APPROVED YOUR NEW DRUG APPLICATION FOR THE MANUFACTURE OF THESE TABLETS, THUS INDICATING THAT YOUR PRODUCT MEETS THE REQUIREMENTS, UNDER PRESENT REGULATIONS, FOR SAFETY AND EFFICACY; AND THAT THE CLINICAL DATA SUBMITTED TO THE FOOD AND DRUG ADMINISTRATION SHOWED THAT THE RESULTS OBTAINED BY THE USE OF "ORINASE" TABLETS AND YOUR PRODUCT WERE THE SAME.

YOU ALLEGED FURTHER THAT YOUR PRODUCT CONTAINS THE SAME QUANTITY OF THE DRUG, TOLBUTAMIDE, AS DO "ORINASE" TABLETS, AND YOU INSISTED THAT YOUR PRODUCT IS EQUALLY AS EFFECTIVE AS THE LATTER. YOUR LETTER THEN GOES ON TO SAY THAT UNDER DATE OF SEPTEMBER 25, 1962, YOUR NEW DRUG APPLICATION WAS MADE CONDITIONALLY EFFECTIVE BY THE FOOD AND DRUG ADMINISTRATION, AND MADE OFFICIALLY EFFECTIVE ON JANUARY 17, 1963. FOR THE REASONS SET FORTH IN YOUR LETTER YOU REQUESTED THAT OUR OFFICE RENDER A DECISION WHICH WILL ENABLE YOU TO PARTICIPATE IN THE FUTURE PROCUREMENT OF TOLBUTAMIDE TABLETS BY THE DEFENSE MEDICAL SUPPLY CENTER.

THE CITED REQUEST FOR QUOTATIONS REQUESTED QUOTATIONS FOR FURNISHING 22,320 BOTTLES OF TOLBUTAMIDE TABLETS, USP, 0.5 GM. (7 1/2 GR.) 50-S, FSN 6505-660-1600, TO TWO DESTINATIONS DURING JANUARY 1963. THE REQUEST FOR QUOTATIONS SPECIFICALLY PROVIDED THAT THE QUOTATION MUST OFFER TO SUPPLY MATERIAL PRODUCED UNDER AN EFFECTIVE NEW DRUG APPLICATION OBTAINED AS REQUIRED BY THE PROVISIONS OF 21 U.S.C. 355, AND FURTHER THAT THE EFFECTIVE NEW DRUG APPLICATION MUST HAVE BEEN ISSUED TO THE SUCCESSFUL BIDDER AT THE TIME OF THE BID OPENING--- NOVEMBER 16, 1962. BY LETTER DATED OCTOBER 2, 1962--- PRIOR TO THE SUBMISSION OF A QUOTATION--- YOU ADVISED THE DEFENSE MEDICAL SUPPLY CENTER THAT YOU HAD OBTAINED A CONDITIONAL EFFECTIVE NEW DRUG APPLICATION AND, ACCORDINGLY, YOUR NAME WAS ADDED TO THE BIDDERS LIST AND THE REQUEST FOR QUOTATIONS WAS MAILED TO YOU AND SEVEN OTHER FIRMS. PRICE RESPONSES WERE RECEIVED ONLY FROM YOUR CONCERN AND FROM THE UPJOHN COMPANY.

THE RECORD INDICATES THAT BEFORE ANY NEGOTIATIONS COULD BE CONDUCTED WITH THE TWO OFFERORS, THE DEFENSE MEDICAL MATERIEL BOARD ADVISED THE DEFENSE MEDICAL SUPPLY CENTER BY LETTER DATED NOVEMBER 15, 1962, THAT IT WAS THE BOARD'S PROFESSIONAL DETERMINATION THAT ONLY UPJOHN'S "ORINASE" MET THE MINIMUM REQUIREMENTS OF THE GOVERNMENT. IN VIEW OF THE CHANGE IN SPECIFICATIONS NECESSITATED BY THE FOREGOING DETERMINATION, THE CONTRACTING OFFICER DETERMINED THAT IT WOULD BE IN THE BEST INTERESTS OF THE GOVERNMENT TO CANCEL THE OUTSTANDING REQUEST FOR QUOTATIONS, USED TO NEGOTIATE THE PROCUREMENT WITH UPJOHN--- THE SOLE MANUFACTURER OF "ORINASE.' A NEW DESCRIPTION WAS PREPARED REQUIRING THAT "ORINASE" BE SUPPLIED.

THE PRACTICE OF MEDICINE IN THE MILITARY DEPARTMENTS IS REGULATED FOR EACH OF THE ARMED SERVICES BY ITS SURGEON GENERAL, AND THE SURGEONS GENERAL COLLECTIVELY CONSTITUTE THE DEFENSE MEDICAL MATERIEL BOARD. THE BOARD, AS CURRENTLY CONSTITUTED, WAS ESTABLISHED BY DEPARTMENT OF DEFENSE DIRECTIVE NO. 5154.18, DATED APRIL 18, 1962, ONE OF ITS FUNCTIONS BEING TO "PREPARE ESSENTIAL CHARACTERISTICS CONCERNED WITH THE MEDICAL (AND/OR MILITARY) APPLICATION OF THE ITEMS. * * *" WHILE THE ACTUAL PROCUREMENT OF MEDICINES IS THE RESPONSIBILITY OF THE DEFENSE MEDICAL SUPPLY CENTER AND THE PURCHASE DESCRIPTIONS ARE WRITTEN BY TECHNICIANS EMPLOYED BY THE SUPPLY CENTER, THE ESSENTIAL CHARACTERISTICS FOR EACH OF THE ITEMS PURCHASED BY THE SUPPLY CENTER ARE ESTABLISHED BY THE DEFENSE MEDICAL MATERIEL BOARD BASED UPON THE BOARD'S PROFESSIONAL EVALUATION AND STUDY.

ARMED SERVICES PROCUREMENT REGULATION 1-1206.1 SPECIFICALLY AUTHORIZES THE PROCUREMENT OF DRUGS ON A PROPRIETARY BASIS "WHEN IT HAS BEEN DETERMINED THAT ONLY A PARTICULAR BRAND NAME WILL MEET THE ESSENTIAL REQUIREMENTS OF THE GOVERNMENT * * *.' IT APPEARS TO BE CLEARLY ESTABLISHED THAT IN THE EXERCISE OF THE AUTHORITY GIVEN BY THE INDICATED DEPARTMENT OF DEFENSE DIRECTIVE, AND PURSUANT TO THE PROVISIONS OF THE CITED ARMED SERVICES PROCUREMENT REGULATION, TO DEFENSE MEDICAL MATERIEL BOARD MADE AN OFFICIAL DETERMINATION WHICH IS BINDING ON THE DEFENSE MEDICAL SUPPLY CENTER. IT MUST BE RECOGNIZED THAT IN A SITUATION SUCH AS IS HERE INVOLVED RELIANCE MUST BE HAD ON THE OPINION OF EXPERTS IN ORDER TO DETERMINE THE MAXIMUM NEEDS OF THE GOVERNMENT, AND UNDER THE CIRCUMSTANCES OUR OFFICE IS NOT REQUIRED TO ATTEMPT TO RESOLVE THE CONTROVERSY.

IN YOUR LETTER OF JUNE 17, 1963, YOU REQUESTED TO BE ADVISED CONCERNING THE STANDARDS SET BY THE DEFENSE MEDICAL MATERIEL BOARD FOR THE TOLBUTAMIDE TABLETS WHICH WERE IN EXCESS OF THOSE PROVIDED BY THE UNITED STATES PHARMACOPEIA, AND INCLUDED IN THE ORIGINAL DEFENSE SUPPLY AGENCY SPECIFICATION. THE JUSTIFICATION FURNISHED FOR THE BOARD'S DETERMINATION IS THAT TOLBUTAMIDE IS A RELATIVELY POTENT CHEMICAL CLOSELY RELATED TO THE SULFA DRUGS AND IS USED ORALLY AS A BLOOD SUGAR REDUCING AGENT IN THE MANAGEMENT AND CONTROL OF CERTAIN TYPES OF DIABETES, WHICH MAY BE MANUFACTURED BY AT LEAST THREE DIFFERENT PROCEDURES. THE EVIDENCE AVAILABLE TO THE DEFENSE MEDICAL MATERIEL BOARD INDICATED THAT THE UPJOHN COMPANY USES A METHOD OF MANUFACTURE WHICH, BY REPETITION DURING THE PAST SIX YEARS AND BY RIGID QUALITY CONTROL DURING THE MANUFACTURING PROCESS COUPLED WITH EXTENSIVE CLINICAL TESTING, HAS CONSISTENTLY PRODUCED A DEPENDABLE, VERY USEFUL DRUG WITH MINIMAL SIDE EFFECTS. THE UPJOHN COMPANY IS THE ONLY KNOWN SOURCE WHICH USES THIS PARTICULAR PROCESS, AND HAS HAD ITS PRODUCT PROVEN THROUGH EXTENSIVE CLINICAL TESTING. IF NOT PROCESSED, INCLUDING TABLETING, BY AN EXPERIENCED MANUFACTURER THE DRUG COULD CONTAIN IMPURITIES WHICH WOULD INTERFERE WITH ITS INTENDED ACTION AND CAUSE SHOCK OR DEATH TO A PATIENT. THE BOARD THEREFORE CONCLUDED THAT IT IS OF VITAL MEDICAL IMPORTANCE THAT THIS DRUG BE OBTAINED ONLY FROM UNQUESTIONABLY RELIABLE AND PROVEN SOURCES WHICH HAVE LONG EXPERIENCE AND NECESSARY KNOW-HOW IN ITS PRODUCTION, AND THAT EVERY PRECAUTION BE TAKEN TO PREVENT THE INTRODUCTION OF ANY VARIABLES WHICH MIGHT ALTER ITS EFFECTS OR INCREASE THE SIDE EFFECTS.

SINCE WE ARE NOT IN A POSITION TO SAY THAT THESE DETERMINATIONS ARE NOT SUPPORTED BY SUBSTANTIAL EVIDENCE, OR THAT THEY DO NOT CONSTITUTE VALID GROUNDS FOR THE ACTION TAKEN, WE MUST ..END :