2 firms fined over illegal promotion of dengue vaccine

MANILA, Philippines — The Food and Drug Administration (FDA) has imposed a fine of P5,000 each on French pharmaceutical firm Sanofi Pasteur Inc. and drug and wellness chain Watsons Personal Care Philippines for illegally promoting and advertising the dengue vaccine Dengvaxia.

In a statement, the FDA said this violates Republic Act  9711 or the Food and Drug Act of 2009 and Administrative Order 65.

FDA director general Nela Charade Puno has warned Sanofi and Watsons that the agency will not hesitate to cancel their License to Operate (LTO) and Dengvaxia’s Certificate of Product Registration (CPR) if they continue to violate the law.

“We are warning local and multinational companies that no one is exempt from the law and they should all comply, or risk having their LTOs and CPR of their medicine products cancelled and revoked,” she added.

Section 2.3 of AO 65 provides that “no pharmaceutical product classified by Bureau of Food and Drugs (BFAD) as prescription or ethical drug shall be advertised or promoted in any form of mass media except through medical journal, publications and/or literature solely intended for medical and allied professions.”

In 2016, however, the FDA’s Center for Drug Regulation and Research (CDRR) has monitored the airing of the advertising materials on dengue vaccination. It also reported the unauthorized promotion of the dengue vaccine in the malls.

Dengvaxia, manufactured by Sanofi, is classified as a prescription product.

In a decision dated Oct. 19, the two companies were slapped by FDA with a fine of P5,000 each.

The two firms were warned that “future violations of FDA-implemented laws, rules and regulations shall warrant stiffer sanctions, including the revocation of their LTO/CPR and the closure of their establishments.”

Puno underscored that “FDA is serious in enforcing its mandate to ensure that the public is provided only with the correct information on the food, drugs, cosmetics and health devices that they use.”

She has directed the CDRR to defer any future application of Sanofi and Watsons LTO and the CPR of Dengvaxia “until and unless the administrative fine imposed by FDA is paid.”

Puno has also instructed the FDA’s South Luzon cluster to check Sanofi’s and Watsons’ compliance with other FDA-implemented laws, rules and regulations.