Dangerous cheaper medicine

There is something seriously ailing the Food and Drug Administration (FDA), a government agency tasked to protect us from harmful products being sold in drugstores and market counters. This came out during the public hearing last Monday of the Senate oversight committee on quality affordable medicine chaired by Sen. Manuel Villar.

Villar has been conducting public hearings on proposed remedial legislations such as Senate Bill 2960, which seeks to amend certain sections of Republic Act 9502, or the Cheaper Medicine Act of 2008. SB 2960 proposes to create a Drug Price Regulatory Board.

At the Senate hearing, concerns were raised on the alleged failure by the FDA to effectively go after unscrupulous traders engaged in illegal activities like selling counterfeit medicine, most of which are reportedly being smuggled into the country. Consumer advocates earlier had taken to task the FDA in particular for its focus on what could be petty matters such as whether boticas or our neighborhood drugstores sell drugs sans prescription forms while glossing over its far more important job of strictly regulating the entry of imported drugs.

This bolsters the perceived lack of consistency in FDA policies since the agency appears to be not strictly looking after the efficacy of these imported drugs of questionable quality. Thus, the FDA was urged to be more stringent in going after drugs manufactured abroad that are being sold here, especially smuggled medicine of spurious quality.

These counterfeit medicine may take the form of real medicine but which are packaged as a branded product. While they may be real medicine, they may have less efficacy than the real branded product.

Since these are counterfeit products, these did not pass through laboratory tests and quality control by the FDA. Hence, this may pose health hazards or endanger the lives of people who may take these medicine of inferior quality or in less dosage.

Worse, some of these counterfeit drugs are reportedly merely made of “gawgaw” or starch but are packaged or bottled seemingly by genuine pharmaceutical companies abroad.

Don’t take this lightly but some of these medicine reportedly being produced by these nefarious counterfeit syndicates are popular branded products for men with erectile dysfunction. They are so-called the “favorite” products of these counterfeiters because there is a demand for these relatively expensive medicine for men willing to pay such an amount thinking these would quietly help them solve their problem.

No less than Philippine National Police (PNP) chief Director General Nicanor Bartolome confirmed that our country has become a veritable market for these counterfeit drugs. The PNP chief disclosed his talks with visiting International Police (Interpol) Secretary General Ronald Noble who told him about the growing trade of counterfeit medicine.

In his discussion with the Interpol head, Bartolome noted their concern over the proliferation of counterfeit medicine that is now deeply hurting the global pharmaceutical industry, which is a huge business. That’s why the Interpol, consisting of 190 member-countries that include the Philippines, is gravely concerned over this development in this part of the world.

In fact, Bartolome revealed, the Interpol is reportedly considering international celebrity, Fil-Am singer Billy Crawford to be part of a universal collaboration to help stir awareness against counterfeit medicine.

Based on Interpol monitoring, Bartolome said counterfeit drugs are reportedly being sourced mostly from at least three countries. Although he did not publicly reveal these countries, it is widely known in the pharmaceutical industry that these smuggled counterfeit drugs are mostly sourced from India and China. This is not to say that the governments of these countries are not doing anything to stop this illegal trade.

While the PNP is not exactly the agency in charge of determining what are genuine and fake medicine, Bartolome said he gave to the Interpol head the PNP’s commitment to keep an aggressive campaign against counterfeit drugs.

The PNP could only do so much to apply law enforcement to help check the proliferation of counterfeit medicine. But the greater burden lies with the FDA as the government agency mandated to do this job.

At that Senate public hearing attended by Department of Health (DOH) Secretary Enrique Ona, it was gathered that the FDA has P191 million for this year. This was even lower than the FDA’s P205-million budget in the previous year. The meager annual budget of the FDA would not have been a problem for the agency had its P700-million income not been reverted to the National Treasury.

The FDA is reportedly not allowed to use its own funds unless it comes up with the five-year development program on the use of its income, supposedly required of it by the National Economic Development Authority (NEDA).

The FDA generates this income from fees collected from companies required to undergo laboratory tests for quality and standard control that the agency conducts on all manufactured food and medicine products that are pre-screened before being sold in the market. So the agency should be a self-sustaining agency. Thanks, but no thanks to the national government, the FDA has to beg for its own funds. 

So how can we expect the FDA to effectively perform its mandate and to do this job not just in Metro Manila but also all over the country when no less than the national government takes away the wherewithal this agency has earned for itself?

The FDA, unlike other drug regulatory authorities, does not even audit companies in other countries.  This means it does not even know if a drug was properly manufactured or just produced by a company in its own backyard. In contrast, most authorities, including those in African countries, audit foreign drug manufacturers. This is embarrassing and constitutes negligence on the part of our FDA, to say the least.

The FDA needs to stamp out the proliferation of counterfeit drugs which are nothing but dangerous cheaper medicine. The FDA needs every resource to really make the Cheaper Medicine Law effectively cure this national malady.