United States General Accounting Office

Washington, DC 20548 

Comptroller General

of the United States

Decision 

Matter of: GlaxoSmithKline 

File: B-291822 

Date: April 7, 2003 

Frank M. Rapoport, Esq., Alison L. Doyle, Esq., and David M. Glynn, Esq., McKenna 

Long & Aldridge, for the protester. 

Maura C. Brown, Esq., Department of Veterans Affairs, for the agency. 

Charles W. Morrow, Esq., and James A. Spangenberg, Esq., Office of the General 

Counsel, GAO, participated in the preparation of the decision. 

DIGEST 

Agency’s decision to procure a drug for the treatment of migraine headaches from 

among four similar drugs solely on the basis of price is reasonable where after a 

detailed medical review the agency determined that any of these drugs would meet 

the agency’s needs. 

DECISION 

GlaxoSmithKline protests the terms of request for proposals (RFP) No. 797-NC-03-

0001, issued by the Department of Veterans Affairs (VA), for a triptan, a drug used in 

the treatment of migraine headaches. Glaxo objects to the RFP terms providing for 

the award of a contract for a single triptan to be designated on the VA’s National 

Formulary.1

 

We deny the protest. 

 

1

 A formulary is a list of prescription drugs, grouped by therapeutic class, which a 

health care organization prefers that its physicians prescribe. Drugs are chosen for a 

formulary on the basis of their medical value and price. The formulary system seeks 

to standardize drug use, ensure availability and consistency of the product for 

nationwide usage, increase the continuity of care, standardize the process for 

evaluating the safety and efficacy of drugs, and manage cost growth. See Agency 

Report at 1; Schering Corp., B-286329.3, B-286329.4, Feb. 2, 2001, 2001 CPD ¶ 19 

at 2 n.2. 
Page 2 B-291822 

The RFP, issued October 23, 2002, sought to develop one source to be added to the 

VA’s National Formulary for a single triptan for supply to the VA and the Department 

of Defense (DOD) under a fixed-price requirements contract for a 1-year base period 

with four 1-year options. The RFP listed four triptans that the agency determined 

met its minimum needs: almotriptan (trade name--Axert), rizatriptan (trade names--

Maxalt and Maxalt MLT), sumatriptan (trade name--Imitrex), and zolmitriptan (trade 

names--Zomig and Zomig-ZMT). Award was to be made to “the lowest price, 

technically acceptable, responsible offeror whose offer conforms to the solicitation.” 

RFP at 34. No technical proposals were requested from the offerors. 

Prior to issuing the RFP, a VA Medical Advisory Panel (MAP) and Pharmacy Benefits 

Management (PBM) Healthcare Group conducted a drug class review of currently 

available oral dosage forms of triptans to determine their efficacy, safety, and 

administration in the management of migraine headaches.2

 The triptans examined 

were sumatriptan, rizatriptan, naratriptan, zolmitriptan, almotriptan, and frivotriptan. 

Agency Report, Tab 14, Drug Class Review, at 1. Among other things, the review 

examined the clinical efficacy, safety and adverse effects associated with each 

triptan as reported in various published clinical trials.3

 The review found that all 

triptan agents are generally well tolerated; that side effects are very similar; and that 

there is insufficient evidence available to conclude that the incidence of other 

adverse events differs significantly between the triptans. The review concluded, “All 

oral triptans are efficacious in comparison to placebo for the treatment of migraine 

headache,” and recommended that only one oral triptan should be on the VA 

National Formulary to be chosen among sumatriptan, zolmitriptan, almotriptan, and 

rizatriptan. The review found that naratriptan and frivotriptan should not be 

considered front line agents because of less favorable pain-free results at 2 hours as 

compared to the other triptans. Id. at 7-8. 

Following the drug class review, the VA’s MAP, PBM, Veterans Integrated Service 

Network Formulary Leaders, and Neurology Advisory Group determined that the 

agency’s minimum needs best would be met by “standardizing on one oral triptan 

that would best treat most patients while enhancing continuity of care throughout 

the VA system.” Although the VA acknowledged that all six of the oral triptans 

examined in the drug class review were approved by the Food and Drug 

 

2

 The VA reports that the MAP is a group comprised of 13 physicians from 

throughout the VA, and DOD, all of whom are actively involved in direct patient care. 

3

 The review centered on the examination of data associated with various 

“randomized, double blind, multicentered, placebo and/or comparative controlled 

clinical outcome studies.” See RFP at 4; Agency Report, Tab 14, Drug Class Review, 

at 3-5. As part of this effort, the reviewers also looked at two recent meta-analyses 

that attempted to overcome the variability inherent in clinical studies by using a 

“number needed to treat” (NNT) analysis. 
Page 3 B-291822 

Administration, the VA decided that only those triptans with a proven safety record 

and that had the ability to produce a pain-free response within 2 hours in the highest 

percentage of patients would meet the agency’s needs. Since the VA’s study 

established that “almotriptan, rizatriptan, sumatriptan, and zolmitriptan 

demonstrate[d] similar outcomes, have similar side effects profiles, and sufficient 

safety data,” the VA’s medical groups determined that any one of these triptans could 

be considered for the National Formulary and that cost should be the determining 

factor in any competition. See Agency Report, Tab 13, Medical Determination of 

Minimum Needs at 1-4; RFP at 4. 

Glaxo, which manufactures sumatriptan, contends that VA’s decision to treat the 

triptans as essentially equal under the RFP lacks a reasonable basis because the 

underlying drug class review supporting this decision was based on inadequate and 

flawed data. Glaxo also asserts that the VA drug class review did not properly 

account for biases in the clinical studies, and that there were discrepancies in the 

meta-analyses (for example, they were allegedly inconsistent with a study that 

showed sumatriptan’s superiority to one of the other approved triptans), such that 

the VA could not have reasonably relied upon the drug class review to conclude that 

all the listed triptans were equivalent. Glaxo further asserts that four recent studies, 

completed since the VA’s December 2001 review, show a “material superiority” of 

sumatriptan over the other triptans. Glaxo argues that the VA should be required to 

consider this more recent data in establishing a single triptan on the formulary and 

directed to amend the RFP to solicit information from offerors regarding the ability 

of the triptans to give patients pain relief. 

The determination of an agency’s minimum needs and the best method of 

accommodating them are primarily within the agency’s discretion. Pfizer, Inc., 

B-277733, Oct. 27, 1997, 97-2 CPD ¶ 119 at 2. 

Here, as detailed above, the VA concluded that either almotriptan, rizatriptan, 

sumatriptan, or zolmitriptan could meet the agency’s needs based on its drug review 

that concluded that the triptans demonstrated similar outcomes, side effects, and 

safety data in the treatment of migraine headaches. Although Glaxo questions the 

methodology and quality of the data used in the review, the VA explains that the 

purpose of the drug review was not to arrive at absolute answers by looking at a 

myriad of studies because studies, which often are funded by various pharmaceutical 

companies, depend on the questions asked, outcome sought and the interpretation of 

the data. 4 Instead, the VA’s drug review generally only studied available medical 

literature, so the VA could decide which pharmaceuticals are the most appropriate 

for the VA’s and DOD’s patients. The VA maintains that the agency’s drug review 

 

4

 For example, the VA points out that the more recent abstract cited by the protester 

used a specific outcome involving the timing of medication administration, and was 

not designed to evaluate overall efficacy in terms of speed of relief. 
Page 4 B-291822 

considered variances in studies in the NNT analyses, and that the drug review 

supports the conclusion that the above listed triptans are interchangeable and 

equivalent for the majority of patients. Further, the VA reports that the more recent 

studies that the protester points to were considered after receiving Glaxo’s agencylevel protest of this RFP, but these studies did not change the VA’s opinion that the 

drugs were therapeutically equivalent for its purposes.5 

We find that the record establishes that the VA undertook a reasonable review of 

medical information prior to concluding that any one of the four triptans identified in 

the RFP is capable of meeting the agency’s minimum needs. Notwithstanding 

Glaxo’s detailed questions about what it maintains are “analytical and procedural 

flaws” in the study, it has not shown that the agency’s reliance on the study results 

was unreasonable. For example, while Glaxo claims that the VA should have given 

more credence to the medical information that suggests that sumatriptan is superior, 

the VA has indicated that the purpose of its review was not necessarily to establish 

the superiority of any one triptan, but to decide from those that were available which 

would best meet the agency’s needs. The VA medical professionals found that all of 

the four listed triptans were capable of meeting the agency’s needs, notwithstanding 

the differences between them. Even accepting that sumatriptan could be considered 

superior, the agency’s determination that the differences between the drugs were not 

material for its purposes has not been shown to be unreasonable. 

Glaxo’s objections to the process and the RFP’s terms are predicated on its assertion 

that the VA should be required to consider additional information, conduct more 

comprehensive meta-analyses, and consider more recent abstract data, which it 

asserts supports the superiority of sumatriptan.6

 To this effect, Glaxo argues that the 

RFP should have requested that offerors provide information on the efficacy and 

safety of their triptan, and provided for a “best value” evaluation which would 

consider the percentage of patients who are pain free at 2 hours, as well as the 

safety of each triptan. 

We disagree. Such an exercise would seem to be unnecessary and duplicative since 

the agency’s medical advisors have already conducted an extensive review of the 

 

5

 The VA explains that it accorded less weight to these recent studies because the 

studies are in abstract form, which the agency views as less reliable, as opposed to 

randomized, controlled trials published in peer-reviewed journals, which was the 

standard that the drug review utilized to measure the efficacy and safety of these 

drugs. 

6

 There is no merit to the protester’s contention that the RFP was ambiguous for not 

specifying the information necessary from offerors to establish technical 

acceptability where, as here, the RFP clearly established price as the sole evaluation 

criterion and did not solicit technical proposals. 
Page 5 B-291822 

triptans, including Glaxo’s additional data, and reasonably concluded that the four 

listed triptans were therapeutically equivalent for its purposes such that any of the 

four would satisfy its needs. The scope of the agency’s review of triptans, including 

the methods for evaluating medical information; the significance given to the 

medical information; and the determination whether drugs are sufficiently 

therapeutically equivalent that only a single drug need be acquired for the National 

Formulary, all involve the agency’s medical judgment and policies, which are 

inappropriate for review under our bid protest function. See Schering Corp., supra, 

at 5 n.11; Pfizer, Inc., B-277733, supra, at 2 n.2; Pfizer, Inc., B-276362, June 6, 1997, 

97-1 CPD ¶ 205 at 6. 7 Also, the agency’s discretion in determining its minimum needs 

extends to the evaluation criteria to be used in evaluating the proposals. See Pfizer, 

Inc., B-277733, supra, at 2-3. Since the VA has reasonably determined that the 

differences in the triptans were not material, there is no basis to question its 

determination to consider only price in determining which triptan to select for the 

National Formulary. 

The protest is denied. 

Anthony H. Gamboa 

General Counsel 

 

 

7

 To the extent that Glaxo questions the wisdom of the VA designating only one 

triptan for the National Formulary, the VA reports that there are procedures that 

permit treating a patient’s particular clinical need with a non-formulary drug where 

the formulary drug is inappropriate. In any event, this also is a matter not subject to 

our review as involving the agency’s medical policies and judgment. See Pfizer Inc., 

B-276362, supra, at 6.