Responding to petitions filed last year by Public Citizen and other advocacy groups, the U.S. FTC for the first time reached out directly to social media influencers to educate them on their responsibility to clearly and conspicuously disclose their relationships to brands when promoting or endorsing products, including drugs and medical devices, through social media. The FTC said Wednesday that it sent more than 90 letters to marketers and influencers, such as celebrities, models and athletes, providing background information on when and how they should disclose a material connection in a social media post. The letters specifically addressed Instagram posts, noting that when the posts are viewed on a mobile device, only the first three lines appear, followed by a "more" button. Since many readers don't click to read more, the FTC said Instagram posts should include the endorsement information before the "more" button. A disclosure included in a string of hashtags or links, especially at the bottom of a long post, isn't sufficient, as they likely are not conspicuous, the FTC said. It also advised against using sponsorship disclosures that are not clear, such as "#sp," "#partner" or "Thanks [Brand]." Public Citizen submitted information to the FTC last September showing 113 influencers had endorsed a product on social media without disclosing compensation relationships. While the watchdog group welcomed the commission's efforts this week, it said the "gentle reminder" to marketers isn't sufficient. "Instagram has become a Wild West of disguised advertising, targeting young people and especially young women," Public Citizen President Robert Weissman said. "That's not going to change unless the FTC makes clear that it aims to enforce the core principles of fair advertising law." The FTC is not disclosing the recipients of the letters.

Enhancing codeine labeling restrictions imposed in 2013, the U.S. FDA issued a safety communication Thursday requiring new labeling changes for all prescription drugs containing codeine or tramadol. The changes include a contraindication, the agency's strongest warning, stating that codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children younger than 12. A second contraindication is to be added to tramadol labeling, warning against its use in children younger than 18 to treat pain after surgery to remove the tonsils or adenoids. Both drugs are to carry a new warning recommending against their use in adolescents between 12 and 18 years who are obese or have conditions such as obstructive sleep apnea or severe lung disease. In addition, the FDA is calling for a stronger warning advising against the use of the drugs in breastfeeding mothers due to the risk of serious adverse reactions in their infants, including excess sleepiness, difficulty in breastfeeding or breathing problems that could result in death.

In the ongoing finger-pointing over U.S. drug prices, the Pharmaceutical Care Management Association (PCMA) is touting the results of a new market analysis it commissioned on whether the rebates drug companies pay to pharmacy benefit managers (PBMs) play a role in higher drug prices. The Visante analysis – which looked at data on the gross and net sales from 2011 to 2016 for the top 118 self-administered, patent-protected, brand drugs approved before 2012 – found no correlation between the rebates and prices, said the PCMA, the PBM trade association. Instead, the analysis showed instances of higher-than-average price increases in drug categories where manufacturers negotiated relatively low rebates, as well as lower-than-average price increases in drug categories where manufacturers negotiated relatively high rebates. For instance, rebates for drugs in the rheumatoid arthritis space increased 11 percent over the time span, but the price increased 125 percent. Rebates for certain diabetes drugs, on the other hand, increased 38 percent, while the price increased 87 percent. The analysis also claimed that PBMs pass through 90 percent of the rebates to insurance plans and patients to reduce their prescription drug benefit costs. "This study debunks the notion that the prices drugmakers set are contingent on the rebates they negotiate with PBMs," said PCMA President and CEO Mark Merritt. "Ironically, many higher priced drugs involve little or no such rebates."

The U.S. Department of Justice (DoJ) renewed its commitment to enforcing the Foreign Corrupt Practices Act (FCPA) to ensure a level playing field for companies doing business abroad. But rather than prosecuting every company or trying to break its own records for the largest fines or longest prison sentences, DoJ's aim is to motivate companies and individuals to voluntarily comply with the law, Principal Deputy Assistant Attorney General Trevor McFadden said this week at the American Conference Institute's 19th annual conference on the FCPA. The department will continue to prioritize prosecutions of individuals who willfully violate the FCPA. When making decisions on whether to charge a company or individual, DoJ will take into consideration voluntary self-disclosures, cooperation and remedial efforts. In cooperation with its international partners, DoJ, where appropriate, will work toward "global resolutions that apportion penalties between the relevant jurisdictions so that companies seeking to accept responsibility for their prior misconduct are not unfairly penalized for the same conduct by multiple agencies," McFadden said.

The FDA is seeking comment on its use of focus groups across its centers, including the drug and medical device centers. The agency uses the groups to get patient and consumer information that can be used in developing variables and measures for quantitative studies, to better understand patients' attitudes about various topics and concepts, and to further explore findings from quantitative studies. According to a notice slated for publication in Friday's Federal Register, the FDA estimates that it will interview a total of 8,800 individuals in its focus groups over the course of a year. Comments on the agency's use of focus groups is due by June 20.