FDA Whips Pharma Firms into Line

FDA Whips Pharma Firms into Line


Follow the MCP  or face sanctions

Flexing its regulatory muscle, the Food and Drug Administration has warned it would l issue sanctions to pharmaceutical companies which do not comply with the guidelines in following the Mexico City Principles or voluntary code of ethics.

Dr. Cynthia Diza, medical specialist 3, officer-in-charge Ethical Market Communications Unit FDA, said the state regulatory body has a guideline that mandates pharmaceutical companies to practice and observe the “Mexico City Principles for Voluntary Code of Business Ethics for the Biopharmaceutical Sector”.

“In delivering the best quality healthcare to patients, it is essential that professionalism and high ethical standard are maintained between the biopharmaceutical companies, the health professionals, and the regulatory body” said FDA in a circular that adopted the MCP.

Diza said…

[pq]…the FDA would issue sanctions against firms which would defy MCP principles, including cancellation of license to operate or issuance of certificate of registration.[/pq]


The FDA official  was invited during the press briefing Tuesday held at the New World Hotel in Makati City, where the Pharmaceutical and Healthcare Association of the Philippines expressed support to the FDA adoption of the voluntary code of ethics for the pharmaceutical sector.

Through the FDA, the country is expected to fully implement the MCP which was endorsed during the 19th Asia Pacific Economic Cooperation  Economic Leader Meeting in Hawaii.

Also, during the 17th APEC Small and Medium Enterprises Ministerial Meeting, the ministers issued a joint statement to promote SME cooperation for innovative growth in the APEC region.

pharmaThe ministers agreed that corruption imposes a significant market access barrier and high costs for SMEs.

To address this challenge, they endorsed principles for voluntary codes of business ethics for specific sectors, including the biopharmaceutical sector.

Dr. Francisco Tranquillo, adviser of the PHAP and assistant to the Dean UP College of Medicine, said MCP stressed the importance of ethical interactions among healthcare professionals and other stakeholders, companies in the biopharmaceutical sector (companies should be guided by six principles namely: healthcare and patient focus, integrity, independence, legitimate intent, transparency and accountability.

Tranquillo said any sponsorship provided to individual healthcare professionals “must not be conditional upon an obligation to prescribe, recommend, or promote” any medicine.

Any sponsorship provided to individual healthcare professionals must not also be conditional upon an obligation to prescribe, recommend, or promote any medicine, he added.

Events should be held in appropriate venues that are conducive to the scientific or educational objectives and the purpose of the event or meeting. Companies should also avoid using extravagant venues or resorts such as in Boracay or hotels in Cebu, Tranquillo said.

Also agreed upon was that hospitality should be limited to refreshments and/or meals incidental to the main purpose of the event and should only be provided to the participants and not extended to individual’s spouse or other guests.

Adoption of the Mexico City Principles highlights the strong commitment of the government to promote a whole society approach to integrity that would ultimately benefit Filipino patients.

[pq]Ethical relationships are crucial to the country’s mission of developing and making quality medicines available.[/pq]


“The implementation of the MCP is a milestone for the Philippine healthcare sector and we call on everyone to respect these principles,” said Thomas Weigold, president of the PHAP.

PHAP, which represents the research medicines sector in the country, composed of 37 member companies, has been following the MC principles since 2011.


– DFF, Medical Observer

One comment

  1. There will always be loop holes on these policies. They might not ask for commitment to use their brands but sponsored MDs will always return the favor and this is the reality. Other countries do not allow Pharmaceutical companies to sponsor an MD to a convention. These loop holes will still be used by those companies who wants to take advantage of their resources.

    Another thing that FDA must focus on is to be strict in approving generic medicines. There are still sub standard medicines that patients are spending but not treated. They shouls also sunction those supplements having false/deceiving advertisements in quad media. Their label says “NO THERAPEUTIC CLAIM” but the ad is promoting to alleviate symptoms and cure disease with proper diet and excercise.