On December 10, 2008, the European Commission published a series of political measures and legislative proposals, the so-called "Pharmaceutical Package." This series included the "Communication on a renewed vision for the pharmaceutical sector," which reflected on ways to improve market access and develop initiatives to boost European Union ("EU") pharmaceutical research. Through the Pharmaceutical Package, the European Commission aims to make pricing and reimbursement more transparent, increase the development of pharmaceutical research within the EU, improve the safety of medicines worldwide, and reinforce cooperation with international partners.
The European Commission has published three separate sets of proposals amending Directive 2001/83/EC on the Community Code of medicinal products and Regulation 726/2004 on medicinal products obtained through centralized procedures:
1. A proposal amending Directive 2001/83 as "regards information to the general public on medicinal products subject to medical prescription" (Information to patient);
2. A proposal amending Directive 2001/83 and a proposal amending Regulation 726/2004 as "regards pharmacovigilance" (The EU pharmacovigilance system); and,
3. A proposal amending Directive 2001/83 as "regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source" (Counterfeit Medicines).… Continue Reading
One of the most frequent strategies employed by advertisers is to let the consumer hear about the advertised product or service from a third party, someone other than the advertiser itself. At its root, an endorsement or testimonial when used in advertising is the advertiser's way of saying, "Don't just take my word for how wonderful my product or service is, listen to this unbiased person whose opinion you should rely upon to make a purchasing decision." The Federal Trade Commission (FTC or Commission) originally published Guides Concerning the Use of Endorsement and Testimonials in Advertising (The Guides) in 1972. The Guides have not been updated since 1980. In January, 2007, the FTC sought comments on proposed modifications and updates to the Guides. In particular, the Commission sought comments on whether so-called "disclaimers of typicality," statements like "Results not typical" or "Your results may vary," should continue to be a valid way to communicate that a testimonial does not represent experiences consumers will generally achieve with the advertised product or service.… Continue Reading
FDA has repeatedly stated over the past year that more enforcement activity in the promotional arena is likely. It appears that time has arrived. Half of FDA's Division for Drug Marketing, Advertising, and Communications' ("DDMAC") citations for misleading advertisements in 2008 were sent in September and October. The citations address typical misbranding issues such as failing to adequately disclose risks, overstating efficacy, broadening indications, and asserting unsubstantiated superiority claims. Whether these citations are the result of DDMAC's increased budget and new hires, or a continued interest by Congress and the Department of Justice over drug industry promotional issues, one thing appears clear: a new era of increased scrutiny is likely here.
A particularly interesting position that DDMAC has taken in a few of the September and October letters concerns descriptions of disorders and the consequences of failing to obtain treatment. For example, in five letters targeting drugs indicated to treat attention deficit hyperactivity disorder ("ADHD"), DDMAC cites marketing materials that list the difficulties and consequences of untreated ADHD (e.g., poor social-emotional development and job success, inability to complete schooling, illegal behaviors, contraction of sexually transmitted diseases, motor vehicle accidents, and physical injury). In each letter, DDMAC takes the position that listing such difficulties and consequences in association with an ADHD drug constitutes an implied claim that the drug will have a positive impact on these issues. If deemed an implied claim, DDMAC requires studies with endpoints that support each claim.
This is similar to DDMAC's position on quality-of-life ("QOL") claims, with health-related QOL claims requiring substantial supporting evidence in the form of adequate and well-controlled studies designed to specifically assess these outcomes.
While the need to have adequate studies to support claims is nothing new, drug manufacturers should remain cognizant of everything listed in marketing materials, including statements concerning the difficulties and consequences of untreated disorders, diseases, or conditions. Drug manufacturers wishing to include such statements must ensure that all implied claims arising from these general statements are supported by substantial evidence (i.e., adequate and well-controlled studies with endpoints targeting each implied claim/impact). Stated otherwise, drug manufacturers must design specific study endpoints to support a disease state description, or must carefully tailor disease state descriptions to pre-existing specific study endpoints.
The Oct. 13, 2008, Pink Sheet (www.thepinksheet.com) provides further detail about DDMAC's increased activity. DDMAC's 2008 warning letters can be accessed at http://www.fda.gov/cder/warn/warn2008.htm.… Continue Reading