BFAD ruling on PPA drugs hit

The administrative order issued by the Bureau of Food and Drugs (BFAD) that allowed the sale of medical products containing phenylpropanolamine (PPA) is highly questionable and "ridiculous."

One of the country’s top pharmacologists who requested anonymity told The STAR that BFAD Administrative Order (AO) 163 issued on Dec. 4, 2000 by then BFAD director Dr. William Torres and approved by then Health Secretary Alberto Romualdez is questionable since it allowed the over-the-counter sale of drugs containing a regulated chemical substance such as PPA.

AO 163 set guidelines for the sale of PPA-containing medicines, which are usually cough and cold treatment tablets and syrups.

The guidelines provide that products with 25 milligrams or below of PPA can be sold over the counter; those with 25 to 50 mg. shall be classified as prescription drugs; while products with more than 50 mg. shall no longer be "registerable."

The source said that AO 163 is anomalous because of the provision allowing the over-the-counter sale of medicines with less than 25 mg. of PPA.

A person can abuse this provision by simply buying several tablets or cough syrups, according to the source, who added that Rep. Gilbert Remulla (LDP, Cavite) and his colleagues should question Torres and Romualdez for issuing AO 163.

Earlier, Remulla said the United States Food and Drug Administration (FDA) declared PPA as unsafe for human consumption in November 2001 after a study by Yale University researchers concluded it can induce stroke and brain problems.

However, the BFAD said that medical products containing PPA are safe, noting that PPA can only induce hemorrhagic stroke when a person takes in a dose of 100 mg or more.

The House oversight committee has decided to look into the continued use of PPA in the manufacture of drugs.

Remulla, who sits in the committee, told reporters last week that the panel has summoned several concerned government officials to its initial inquiry set for Wednesday next week.

He said those invited include Health Secretary Manuel Dayrit and the heads of BFAD and the Dangerous Drugs Board.

Remulla said the committee will ask them why they have failed to enforce Republic Act 9165, known as the Dangerous Drugs Act of 2002, which bans PPA because it has been found to cause strokes, especially among women.