Cheaper drugs — where’s quality assurance?

I am a practicing pediatrician, academician and researcher. Recently, I had a spate of patients who had inquired on the issue of cheaper medicines which the government is pushing and which President Gloria Macapagal-Arroyo is reportedly about to sign the said bill at the soonest. 

The primary query was — are the cheaper drugs just as good as the innovators? 

Interestingly, this issue has NEVER been taken up by the lawmakers and has been relegated as a given in the equation of drugs manufactured and distributed in the Philippine market.  In short, it is presumed by many, as endorsed by media and TV personalities, that ALL generic drugs are the same.

Are they?

There are many drugs that bank on the issue of bioequivalence (BE) in order to be classified as being the same as the innovator.  Bioequivalence “means the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study. Where there is an intentional difference in rate (e.g., in certain controlled release dosage forms), certain pharmaceutical equivalents or alternatives may be considered bioequivalent if there is no significant difference in the extent to which the active ingredient or moiety from each product becomes available at the site of drug action. This applies only if the difference in the rate at which the active ingredient or moiety becomes available at the site of drug action is intentional and is reflected in the proposed labeling, is not essential to the attainment of effective body drug concentrations on chronic use, and is considered medically insignificant for the drug.”1

The issue on BE is relevant and timely in the advent of the Cheaper Drugs bill that is looming in Congress, the Senate and the Palace.  These lawmakers and people of governance must answer the question — how do you assure the public of the QUALITY of the drugs that are being sold?

The US FDA Orange Book contains a complete list of drugs that require BE testing.  Many of them fall within the class of cardiovascular drugs, anti-epileptics, anti-asthma medications, anti-psychotics, some antibiotics, anti-TB and anti-HIV agents, regulated drugs, to name a few.

The Department of Health and the Bureau of Food and Drugs under the DOH arm is tasked to take the lead role in making sure that a concrete guideline be provided to the Food and Drug authorities on ensuring Quality Assurance of drugs manufactured, distributed and sold in the Philippines. It had taken several years before the moratorium on bioequivalence was lifted and is taking a longer time for a lot of the local pharmaceutical companies (whether local manufacturers or importers of finished products) to have many of their drugs tested for bioequivalence.  While dissolution testing can serve as surrogate markers, they ARE NOT the gold standard for claiming bioequivalence of generic products to the innovator. 

According to these companies, the COST of a BE test is the major issue.  It is not.  To have a product tested for bioequivalence would range between P800,000 to P2.5 million depending on the compound and the equipment used.  But this is a small price to pay — compared to how much they spend for promotions and “field trips” of doctors and pharmacists and pharmacy owners — to assure the public that the drug they make, distribute and sell are equally effective as the innovator brand. 

We had called the attention of Secretary Francisco Duque III on the matter, and had even attempted to set up several meetings with him, but his schedules would not allow us to fit in.  It is a wonder how he can fit in for a shoot for Star Margarine, and yet not find time to sit down with concerned people on the merits of having mandatory BE testing comparable to the US FDA requirements. 

Government officials cannot use the sorry excuse that there is not enough testing centers locally.  In 1996, AusAID had funded the Philippines program on National Drug Policy, the transfer of technology of BE testing.  The first BE center was established in the University of Santo Tomas.  Thereafter, two other centers were formed — University of the Philippines-Philippine General Hospital and De La Salle University-Emilio Aguinaldo.  This program was funded in order to preserve the Quality Assurance pillar on drugs manufactured, distributed and sold in the Philippine market. 

Almost a decade later, while Filipinos clamor for cheaper drugs, and rightly so, the question still remains.  With so much at stake here, how are we to assure the public that the generic drugs that are being peddled in the local market are BIOEQUIVALENT?  I believe that our health and government authorities must remember the saying that “the most expensive drug is the one that doesn’t work”.

While we are all supportive of a bill that provides Filipinos access to cheaper drugs, let there be a supporting guideline that is implemented NOW to ensure quality assurance, before the bill is signed.  Otherwise, only the Filipino public will be at the losing end of this raw bill . — BENJAMIN G. CO, MD, FPPS, FPSECP, Professor of Pediatrics and Pharmacology, Executive Director, Center for Drug Research, Evaluation and Studies, Inc., University of Santo Tomas Manila, Philippines, Chair, Pharmacy and Therapeutics Committee, Asian Hospital and Medical Center, Inc.