CHIZ WANTS BFAD TO EASE LICENSING REGULATIONS FOR INTERNATIONALLY ACCEPTED DRUGS

Senator Chiz Escudero wants the country's Food and Drug Administration (FDA) to recognize and simplify registration process for internationally renowned medicines with pending licensing applications in the country.

Escudero, chairman of the senate finance committee said entry to the country of cheaper medicines with international acceptance is being hampered by laborious process in the FDA.

The senator pored over the FDA's rules and procedures on registration and licensing of medicines from abroad during the Department of Health's (DOH) budget hearing before the senate this week.

"There are a lot of medicines available abroad, sometimes even more potent and definitely cheaper that takes so long to be approved here. These are widely accepted, prescribed and used in advance countries in Europe and America. Even in Singapore and Japan. If it is good for them, isn't it for us too? Are there any particular drugs that discriminate potency among racial origins?"

"None your honor," FDA Director Nazarita Tacandong replied. She said the average turn around for registration of drugs in the country, particularly those coming from abroad is 65 days.

"I don't think that's true. I have received complaints and some applicants can even attest that it does not take 65 days. From the time they apply, what I know is it takes two to three years before approval is granted," Escudero told the agency.

FDA said it will only take 65 days if and when the applicant company has complied with all the paper and clinical requirements. The latter, the agency said is the reason for the delay that could take up years to meet.

Escudero said the FDA should seriously develop a policy shift by relaxing licensing requirements with internationally approved drugs and take advantage of globalization. He said the Philippines can utilize what other countries have already accomplished for clinical testing of medicines that address common health issues.

"The FDA's counterparts in other countries have already laid down standardized processes for drug testing and licensing. If these are registered in certain countries especially with known strict quality standards, the FDA can just simply ask the applicant company to submit that registration here and we adopt it. Why insist on doing it over and over again?"

Escudero added that outside the mandate of the Cheaper Medicines Law, the FDA by way of policy can make certain medicines available in the Philippine market.

"We can coordinate with other counterparts and if the agency is satisfied with what these countries are doing or have done and to the extent applicable to us and which satisfies our comfort level, then we can already facilitate access to medicines which are already available to other nationals."

DOH Secretary Enrique Ona said the department will "review and talk it over."

"We want to pursue this to make access to health needs equitable but we also want to promote our home-grown products to be accepted in other countries without also going through the bureaucratic maze because we are able to draw up an agreement between countries."