The pharmaceutical industry is highly competitive, which creates an environment

in which companies naturally attempt to promote their products as beingbetter or superior to competitive products. FDA standards for comparative claims, however, are quite high and generally require head-to-head comparative trials. Comparative claims must be supported by sound scientific data, which generally means adequate and well-controlled clinical trials. FDA's regulations provide that an advertisement is "false, lacking in fair balance, or otherwise misleading . . . if it . . . [c]ontains a drug comparison that represents or suggests that a drug is safer or more effective than another drug in some particular when ithas not been demonstrated to be safer or more effective in such particular by substantial evidence or substantial clinical experience."

FDA has stated that comparative claims and claims of superiority are subject to

the same standards of review as for efficacy and safety claims in a product's approved labeling. Thus, advertising and promotional labeling are false or misleading if they contain representations or suggestions that a drug's safety or effectiveness is comparable or superior to another drug in some particular when such comparability or superiority has not been demonstrated by substantial evidence or substantial clinical experience.

In addition, comparative promotional claims should be consistent with the approved

labeling for the products compared. For example, a manufacturer cannot compare the safety or efficacy of its product for a given indication to that of a competitor if the manufacturer's product is not approved for that indication.

Considering the information above, please review the claim below:

Drug x helps to relieve seasonal allergy symptoms and it has been shown to be the fastest acting allergy drug on the market.

Select the correct answer below with the understanding that the allergy drug reference above (x) has been approved by FDA, and the company has provided clinical support and evidence that the drug has been tested against most other allergy medications on the market.

1. This claim is acceptable and there is nothing concerning about it.
2. The claim is unacceptable in its entirety.
3. This claim is partially acceptable such that the first half of the claim is accepted, but the second half is not acceptable.
4. This claim is partially acceptable such that the first half of the claim is unacceptable, but the second half is acceptable.