News: FDA's Social Media Insight

News bites

Vaccines for GAVI

Pfizer and GlaxoSmithKline have entered into separate agreements with the GAVI Alliance to supply pneumococcal vaccines to developing countries. Each company has agreed to supply as many as 480 million doses of their pneumococcal vaccines

Read more at www.PharmTech.com/gavivaccines

BMS acquires Inhibitex

In a deal worth almost €2 billion, Bristol-Myers Squibb has commenced a cash tender offer to purchase all outstanding shares of Inhibitex. The transaction will provide BMS with an oral nucleotide polymerase inhibitor that is currently in Phase II development for the treatment of hepatitis C.

Read more at www.PharmTech.com/bmsdeal

Sanofi boosts start-up

Sanofi is extending a helping hand to start-up biotech company Warp Drive Bio by providing funding, access to its strains library and expertise in natural products. Two US venture capitalist firms will also invest in the start up, with all three offering funding that could amount during $125 million in the next five years.

Read more at www.PharmTech.com/sanofiboost

Ranbaxy's consent decree

Pledging to strengthen procedures and policies to ensure data integrity and comply with cGMP, Ranbaxy has signed a consent decree with the FDA. The company will also make a provision of $500 million to resolve liability in connection with an investigation by the US Department of Justice.

Read more at www.PharmTech.com/ranbaxy

FDA's social media insight

How can pharma make use of social media opportunities without running afoul of regulators? Pharma companies worldwide have been waiting for an answer to this question for years, but progress has been slow. In the US, however, the FDA recently released a draft guidance entitled Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices that includes recommendations on responding through online channels such as forums and chat rooms. The guidance only deals with social media in the specific context of unsolicited information requests, but it demonstrates that regulators are considering how social media affects different aspects of pharma's business activities.

In terms of off-label information, the internet and social media have a big role to play. Firms often encounter requests for such information about their products through websites, discussion boards, chat rooms or other electronic forums. Many companies, wary of invoking the wrath of regulators, may shy away from responding, but the guidance acknowledges that it can be in the best interest of public health for companies to step in as other participants in the discussion may not have the most uptodate information about their products. In the guidance, the FDA also states that it acknowledges that firms are capable of responding to information requests in a "truthful, non-misleading, and accurate manner". Despite this, however, the FDA is concerned about the public availability of responses.

Sneaky advertising

The FDA's main concern is that firms may post detailed public responses to questions about off-label uses of their products in a way that communicates unapproved information to those who have not asked for it, such as other participants browsing the discussion.

The FDA recommends that firms only respond to public requests that pertain specifically to their own named products. Caution should also be taken when responding to more general questions. For example, for a question such as "What drug/device can be used for Condition X", the firm should not respond if its product has not been FDA-approved or cleared for the mentioned condition. A safer question to respond to is a specific request such as "Can Drug/Device Y be used for Condition Y", where Y is a named product of the company. To alleviate the concern mentioned above, however, the FDA states that the reply should be limited to providing contact information that allows people to follow up through a one-to-one phonecall or email.

If a firm responds to unsolicited requests for off-label information in the manner described in the draft guidance, the FDA said that it will not use such responses as evidence of a firm's intent that the product be used for unapproved or cleared uses.

European developments

In Europe, news on social media regulations has been quiet. Last year, however, the Association of the British Pharmaceutical Industry (ABPI) published a guidance that suggested best practices for managing adverse events and other pharmacovigilance data from the internet and social media tools. Read more about this at www.Pharmtech.com/abpiguidance

Although the FDA and the EMA work differently, they tend to draw from one another's regulations and guidelines. The FDA's draft guidance could eventually impact how European regulators approach social media issues.

The FDA is developing additional draft guidances that deal with social media, but the agency says that it is difficult to provide a timeline for their issuance because of extensive work and review processes. According to a note on the FDA website, the main priority areas the agency is striving to address are fulfilling regulatory requirements when using tools associated with space limitations, fulfilling postmarketing submission requirements, on-line communications for which manufacturers, packers, or distributors are accountable, use of links on the internet and correcting misinformation.

If European regulators do decide to follow guidances from the FDA, however, it will take time for them to be transferred to Europe. In particular, the ban on direct-to-consumer advertising could make it more difficult for European companies to exploit social media.