Sanofi, Watsons warned of losing licenses over dengue drug

The Food and Drug Administration (FDA) recently penalized French pharmaceutical giant Sanofi Pasteur Inc. and drug and beauty products chain Watsons Personal Care Philippines for illegally promoting and advertising the dengue vaccine, Dengvaxia.

The FDA said this was a violation of Republic Act 9711 or the Food and Drug Act of 2009 and Administrative Order No. 65.

Section 2.3 of AO 65 provides that “No pharmaceutical product classified by BFAD (Bureau of Food and Drug) 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.”

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

In a decision dated Oct. 19, FDA slapped both Sanofi and Watsons with a fine of P5,000.00.

Also, they were warned that future violations of FDA-implemented laws, rules and regulations would warrant stiffer sanctions, including the revocation of their license to operate/certificate of product registration and the closure of their establishments.

FDA director general Nela Charade Puno warned Sanofi and Watsons that FDA would not hesitate to cancel their license to operate and Dengvaxia’s registration if they would continue to violate the law.

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

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

“We are warning local and multinational companies that no one is exempt from the law and they should all comply.”

Sanofi Pasteur Inc. is an affiliate of Sanofi Pasteur SA, a global pharmaceutical company engaged in the manufacturing, production and distribution of medicines including vaccines.

Puno directed the FDA’s CDRR to defer action on any future application of Sanofi and Watsons LTO and the CPR of Dengvaxia until and unless the administrative fine imposed by the FDA was paid.

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