128 - We are considering creating a web site that is for healthcare professionals (HCP)only. What are the minimum requirements for 'gating' the site? As this may span multiple products, DIN is not appropriate. We will be looking to use a UserID/Password combo. What is our responsibility as a pharmaceutical company to ensure that the person signing up for an account is indeed a HCP? Can it be as simple as getting the HCP to agree to the 'Terms of Use'?
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For prescription products and for drugs indicated to treat/cure Schedule A diseases, the gate is required to pose a true barrier restricting consumers from having access to the site. The relevant legislative authority is Section C.01.044 of the FDR and Section 3 of the FDA. Simply indicating an agreement to the "terms of use" (e.g. "I confirm that I am an HCP") would not appear to meet the requirement as this would not pose a true barrier to entry for non-HCP audiences. This does not show intent to restrict the messaging to HCPs. There are various ways to successfully gate a site. Many clients meet the gating requirement through passwords provided to the HCPs, but there are other options as well. For example, some sites are not accessible except through a link emailed to the HCP or a disk provided to the HCP which takes them into the site. As these 'access keys' are distributed only to the HCP on the front end, there is no need to have a password on the site (unless there are other ways to get to the site). We are aware that there are various uses of technology to provide effective gates. We recommend consulting an e-supplier. The PAAB will review the landing page to ensure that it meets the DTC requirements. Note that for non-Rx Products which are NOT indicated to treat/cure Schedule A diseases, a gate is not required. Please call the PAAB office if you have further questions regarding gating websites.
