BNUMBER:  B-277733 
DATE:  October 27, 1997
TITLE: Pfizer, Inc., B-277733, October 27, 1997
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Matter of:Pfizer, Inc.

File:     B-277733

Date:October 27, 1997

Kenneth B. Weckstein, Esq., and Shlomo D. Katz, Esq., Epstein, Becker 
& Green, P.C., for the protester.
David C. Hammond, Esq., W. Bruce Shirk, Esq., and Mary Baroody Lowe, 
Esq., Powell, Goldstein, Frazer & Murphy LLP, for the Bayer 
Corporation, an intervenor.
Maura C. Brown, Esq., and Philip S. Kauffman, Esq., Department of 
Veterans Affairs, for the agency.
Mary G. Curcio, Esq., and John M. Melody, Esq., Office of the General 
Counsel, GAO, participated in the preparation of the decision.

DIGEST

Agency properly may seek offers of two different formulations of a 
drug under a single solicitation, and make a single award based on low 
price, where agency determines that either formulation will meet its 
needs. 

DECISION

Pfizer, Inc. protests solicitation No. M5-Q5-97, issued by the 
Department of Veterans Affairs (VA) for long-acting nifedipine.  
Pfizer principally argues that the solicitation improperly provides 
for a single award for long-acting nifedipine, ignoring the 
differences between two competing nifedipine products.

We deny the protest. 

The solicitation was issued as part of a broader program underway at 
the VA to standardize pharmaceutical and medical/surgical items in 
order to achieve concentrated buying power by creating "national 
formularies" for various drugs.[1]  The VA issued the solicitation 
here to establish a fixed-price contract for long-acting nifedipine 
tablets to be included on the national formulary.  The solicitation  
provides for the award of a single contract based on low price.
Two manufacturers currently produce long-acting nifedipine--the Bayer 
Corporation, under the name Adalat CC, and Pfizer, under the name 
Procardia XL.  Pfizer maintains that it is improper to compete these 
products against each other, and to make a single drug award, because 
they are not the same; they are neither generic equivalents nor 
bioequivelants as defined by the Food and Drug Administration (FDA).  
In this regard, Pfizer explains that the two have different dosing 
ranges, Procardia can be taken with or without food while Adalat must 
be taken on an empty stomach, and levels of Procardia stay constant in 
the bloodstream over 24 hours, while levels of Adalat vary.  Pfizer 
also notes that the two products are not therapeutically equivalent 
because they have different effects on blood pressure, and that 
Procardia is FDA approved for treatment of both hypertension and 
angina, while Adalat is approved only for treatment of hypertension.  
Pfizer believes the two products should be procured separately.

The determination of an agency's minimum needs, and the best method of 
accommodating them, are matters primarily within the agency's 
discretion.  Premiere Vending, 73 Comp. Gen. 201, 206 (1994), 94-1 CPD  para.  
380 at 7.  The VA does not dispute that, because Procardia and Adalat 
are formulated differently, they are not generic equivalents or 
bioequivelants.  Rather, the VA has determined that since the two 
drugs are pharmaceutically equivalent--they both contain the same 
amount of nifedipine--either formulation will meet its need for 
long-acting nifedipine.  The VA states that, for its purposes, the 
differences which result from the different formulations--the 
absorption rate, the dosing range, and whether the drug can be taken 
with food--are not clinically significant, and will not produce 
significant side effects.  Similarly, the VA does not consider 
significant for its purposes the fact that Procardia is approved for 
treatment of both hypertension and angina (while Adalat is approved 
only for treatment of hypertension), since there are angina drugs 
available on the national formulary.  We conclude that, since the VA's 
requirement is for long-acting nifedipine, and the VA has determined 
it has no need for the additional qualities of Procardia, there is 
nothing improper in the agency's decision to make a single drug 
award.[2]

Alternatively, Pfizer argues that, if the drugs are competed against 
each other, the award decision should take into account the 
differences in the drugs, as well as the effect that switching drugs 
will have on patients, and not be based on price alone.  However, an 
agency's discretion in determining its minimum needs extends to the 
evaluation criteria it will use.  Pfizer, Inc., supra, at 3.  As 
discussed, the VA has found that the differences in the two products 
are not material for its purposes, and that for the majority of 
patients who switch drugs there will be no adverse effects.[3]  These 
are medical judgments that we will not question.  Id. at 6.  
Accordingly, there is no basis for precluding award based on price.
  
Pfizer argues that if award is based on price alone, the VA must 
consider the cost impact that will result if Adalat wins the 
competition and patients with angina must take a second medication.  
Since the VA's requirement is for long-acting nifedipine for its 
national formulary--a need that either Procardia or Adalat will 
meet--the agency properly may base its price evaluation on the prices 
of the offered products; there is no basis for requiring the agency to 
consider cost savings that may result from differences in the two 
products that are unrelated to its requirement.

The protest is denied.

Comptroller General
of the United States

1. The term "national formulary" refers to the VA's selection of a 
limited number of common drug items for unrestricted use by any 
prescriber.  The selection of drugs for the national formulary is 
designed to standardize care for patients throughout the VA's national 
network of medical care facilities and to reduce costs.  

2. Pfizer argues that the drugs should not be competed against each 
other because, if Adalat is selected, patients currently taking 
Procardia will be switched to Adalat.  According to Pfizer, this 
switch will have adverse effects on the patients.  As we recently have 
held, however, the medical policies and judgments involved in an 
executive agency's decision to utilize a single drug award are not 
appropriate for consideration under our bid protest function.  Pfizer, 
Inc., B-276362, June 6, 1997, 97-1 CPD  para.  205 at 6.  

3. Pfizer asserts that the VA did not study the effects of switching 
patients from Procardia to Adalat.  However, the record shows that the 
VA did conduct such a study.  See Michael B. Ganz, M.D., and Brett 
Saska, Switching Long-Acting Nifedipine, Fed. Practitioner, May 1997.  
In any case, the need for and accuracy of the study are matters of 
medical judgment that we will not review.