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FDA stops Sanofi from airing ad on vaccine

THE Philippine Food and Drug Administration has stopped giant pharmaceutical company Sanofi Pasteur Inc. from airing television and radio advertisements on the controversial dengue vaccine, Dengvaxia, which procurement at the time of former Presidenf Aquino remains under investigation by the Senate. 

In a statement issued on Tuesday, FDA lawyer Emilio Polig said airing the advertisement violated Administrative Order No. 65 s. 1989, prohibiting advertisement in any form of prescription or ethical drug.

The FDA’s Center for Drug Regulation and Research has monitored the airing of the advertising materials on dengue vaccination. 

It has also reported the unauthorized promotion of dengue vaccine in the malls. 

In the “Summons with Cease and Desist Order”  issued by FDA against Sanofi last Dec. 13, 2016, Sanofi was directed to cease and desist from disseminating advertisements for Dengvaxia in any form of mass or social media. 

Sanofi was also directed to stop activities promoting and marketing the vaccine. 

However, as of Dec. 15, 2016, the company had failed to comply with FDA’s directive to take down the said advertisements. 

FDA Director General Nela Charade G. Puno stressed that since Sanofi had not complied with the order, they issued summons directing them to cease and desist from airing the advertisements and “Show Cause” why they should not be penalized for violating the law.” 

Puno added to ensure immediate compliance, “the FDA already sent letters to TV and Radio Stations directing them not to air the said unauthorized ads.”

Puno also said the FDA would monitor compliance by Sanofi and the stations. 

“We are looking forward to their cooperation in our 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 pointed out.

Puno earlier said that based on their investigation, while the papers were complete, they found what appeared to be a deviation from the usual protocols during the FDA’s approval of the vaccine, under the watch of past officials.

The Senate Blue Ribbon Committee, chaired by Sen. Richard Gordon, is investigating the “rush” in the Department of Health procurement of the P3.5 million worth of Dengvaxia under former Health Sec. Janet Garin shortly before the May 2016 elections.

Gordon also pointed out that testing for the new vaccine had not been completed yet when the government procured it.

This was supported by Dr. Anthony Leachon, an independent health advocate and member of the Dengue Expert Panel convened by the DOH, who cited calls from the scientific community for a more lengthy study first to ensure the safety of the beneficiaries.

He also questioned how a P3.5 billion fund was allocated for a single vaccine when the entire vaccination program of the DOH totalled P3 billion.

He pointed out the procedural lapses in the dengue vaccination program, the evident conflict of interest in the members of the formulary executive community, and the supposed bloating/overpricing of the particular drug.

He cited the timeline of the DOH dengue vaccination program, starting from the meeting between Aquino and Sanofi representatives during the Climate Change Summit in Paris on Dec. 2, 2014. 

He said the FDA approval was then issued on Dec. 22, and subsequently the Formulary Executive Council defense of the economic study on Jan. 17, 2015. 

This was followed by the signing of the purchase request for two million doses on Jan. 21, 2015 despite the absence or inclusion of the drug in the national drug formulary for the use of public funds, and the approval on Jan. 25, 2015 of the budget.

But Garin, a former congresswoman and partymate of Aquino at the Liberal Party, insisted on the need for the procurement due to the rising incidence of dengue.

Although he does not want to impute malice, Gordon emphasized that the circumstances in the  procurement of the vaccine was suspicious from the top to the bottom.

Gordon admitted he was baffled by the “rush” in the purchase of the vaccines when only 250 people per year died from the disease with over 200,000 persons afflicted, which accounts for 0.01 percent of the population and dengue not being among the Top 10 health afflictions suffered by the people. 

“It behooves us in the government to see to it that when we get this kind of medication, we get the best and we must see to it that we examine the test protocol and results and that we come out with all the due diligence required of a good father to a child,” also said the senator.

On Dec. 6, 2016, the Blue Ribbon conducted its first hearing on the issue following the deaths of two children, who received the first dose of the vaccine in April. 

While no appropriation was made for the purchase, Gordon noted that funds were immediately made available toward the end of year.

Topics: Philippine Food and Drug Administration , Sanofi Pasteur Inc.
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