Pharmaceutical Commerce - March 2010 - (Page 7)
AstraZeneca’s Principles for Product-Related Online Communications
Industry anticipates meaningful guidance from FDA on use of social media
By Bob Perkins, Vice President, Public Policy and Promotional Affairs
FDA held two days of meetings in November to address regulation of drug communications on the Web and with social media tools, and solicited industry comment (see also p. 9). AstraZeneca filed comments, excerpted below, during the recently closed comment period. FDA is expected to propose regulations later this year. AstraZeneca believes that five principles should be at the core of any company engagement in social media: to be truthful and accurate; to respect the interests of patients; to protect and advance patient health; to be transparent; and to respect the views of others.… As an expert on our approved products and the conditions they address, AstraZeneca believes that we have an obligation to participate in social media and that our responsible participation is in the interests of patients, caregivers, health care providers, and the general public. Our active participation can provide information to help ensure that patients get the appropriate medicine at the right time and that it is taken in the right way.
Our engagement will also provide a known, identifiable presence to answer questions and provide accurate information on our medicines and their approved usage …
A new regulatory framework
... We recommend that FDA consider a regulatory framework that defines, distinguishes, and distinctly regulates three types of communications on the Internet and in social media. There are: 1. Company-controlled, hosted online communications … placed on web sites and other online properties that are under the control of a product sponsor. Controlled sites and properties would be defined as those that the sponsor owns, operates, or where the sponsor retains editorial control. Such communications would include company-owned product information web sites, company controlled disease information sites, company sponsored and controlled content areas on third party web sites such as Facebook. For such communications, the company should
be held accountable in a manner that reflects the letter and spirit of FDA’s promotional rules for advertising. 2. Company-controlled communications. . . . that a product sponsor places or provides for use by web sites and other online properties that the sponsor does not control and where such communications are used in the form, manner, and context for which the sponsor provides it. Such communications include company sponsored and created advertisements or banners on third party web sites. They can also include company provided content such as videos, online tools, or articles. Where these communications include information on the uses of medicines or medical devices, the sponsor would have to ensure that the communication is appropriately balanced and includes information and links to further information on the risks of the medicine or device. The guidance should require the sponsor to provide this information to an extent and in a form that is appropriate to the size or other limitations of the site or forum. 3. Real-time, social media participation communications [including] company realtime, social media interactions on web sites and online forums that are not companycontrolled. Such communications typically occur in chat areas, comment areas or as an integral part of the operation of the web site (for example in pop up or pop over windows created by the web site creator). Such communications would be considered consistent with law and regulation where they are:
• appropriate to the context and intended audience of the site and the initial interaction that the product sponsor is participating in; • when examined in that context, as a whole provide an accurate and balanced picture of the risks and benefits of the sponsor’s products, and; • preserved along with its context, where feasible, for review and audit by the product sponsor and, at its discretion, by the FDA. … In contrast to these three types of communications, we believe that the FDA should define Independent Communications to include content that a product sponsor does not provide or post or material that was originally provided but that has been altered by others outside the control of the product sponsor. An example of such communication would be Google Sidewiki. Such communications would not trigger obligations from the product sponsor. In order to effectuate this framework, we urge the agency to adopt guidance that: 1. Clarifies for which communications the FDA will hold a product sponsor accountable. 2. Provides instruction on how to apply promotional rules to space-restricted digital media. 3. Clarifies the treatment of social media conversations. 4. Clarifies how existing requirements for reporting adverse events will be applied to realtime, social media communications.
Follow the Money … Where Healthcare Policy is Headed
CMS will be changing reimbursement practices regardless of how healthcare reform plays out
By Rita Numerof, PhD, Numerof & Associates, Inc.
Attention on healthcare policy is currently focused on House and Senate lawmakers as they work to reconcile their health care bills. With the recent election of Republican Senator Scott Brown, and calls for “hitting the reboot button” on healthcare reform, many in the industry consider the “sit back and wait” approach a prudent strategy – particularly in light of what happened—or didn’t— in 1993 with the Clinton Administration’s failed attempt to reform the system.
What many in the industry fail to recognize is that achieving Congressional consensus on health care reform is not a prerequisite to instituting far-reaching administrative changes to healthcare policies. As example, with the material support of the former Healthcare Financing Administration (HCFA), now known as Centers for Medicare and Medicaid Services (CMS), Diagnosis Review Groups (DRGs) were first implemented as pilot programs in the New Jersey in 1980. By 1983,
HCFA decided to implement DRGs in hospitals nationwide. It’s hard to imagine a change to healthcare as sweeping as DRGs—all accomplished without Congressional approval. Even if healthcare reform dies in Congress, HHS Secretary Sebelius is unlikely to stand by and pilot CMS into bankruptcy. The focus of federal funding opportunities over the past year is consistent with the multi-pronged approach the administration is taking toward improving quality and reining in cost. Federal grants driving this reform focus have been available since mid-2009. Grants offered have been directly aligned with the administration’s avowed intent to achieve better quality and reduce cost through: aggressively implementing EMRs; conducting comparative clinical effectiveness research (CER) to improve outcomes; and promoting more patient-centered primary healthcare delivery, particularly for disadvantaged populations. Because of the dollars available (over $1 billion) and current focus on CER as a way to increase quality and reduce cost, the fund-
> Rita Numerof , PhD, is co-founder and president of Numerof & Associates, Inc. (St. Louis, MO; nai-consulting.com), a strategic consulting ﬁrm that specializes in healthcare and life sciences, and other dynamically changing industries. She has degrees from Syracuse University and Bryn Mawr College, and is an adjunct faculty member of the Olin School of Business at Washington University in St. Louis. ing schedule for CER related grants has been particularly aggressive. Requests for proposals and funding opportunity announcements for CER related activities from AHRQ and HHS were posted early in 2009. Many new grants were posted in December 2009 with deadlines as short as 30 days. Some in the industry may have failed to realize that collection of data for CER is well underway and is being driven as an integral part of EMR implementation. Almost weekly, HHS and AHRQ issue new RFPs for projects related to achieving the administration’s healthcare
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Table of Contents for the Digital Edition of Pharmaceutical Commerce - March 2010
Pharmaceutical Commerce - March 2010
Business & Finance
Brand Marketing | Communications
Supply Chain | Logistics
Packaging & Drug Delivery
Legal | Regulatory
Executive Training & Development
Pharmaceutical Commerce - March 2010