The U.S. FDA: A global healthcare authority?

Posted AtWistechnology.com

As most people in the life science industry around the world know, the U.S. Food & Drug Administration is the prime drug, device and diagnostic regulatory agency in the U.S., but it is also quickly becoming an international organization, if not the predominant organization around the world for establishing the key criteria for approving and regulating new drugs, devices, and diagnostics (as well food).

In a press release earlier this year (March 14), the FDA announced it had received approval from the U.S. State Department to establish eight full-time positions at U.S. diplomatic posts in China, pending authorization from the Chinese government. According to the same press release the FDA will also hire five additional local Chinese nationals to work with the FDA staff in Beijing, Shanghai, and Guangzhou.

The world according to FDA

Much like the multinational Big Pharma companies, the FDA has created an international organization with it Office of International Programs run by Associate Commissioner Melinda Plaisier. The “world according to the FDA” is composed of two international divisions currently:

• The Americas, Asia, Africa, and Middle East division.
• The Europe and Harmonization Division.

Each division has several assistant directors with responsibility for sub-regions.

According to the FDA, U.S. imports reached over six million shipments worth $80 billion in 2000 (eight years ago). These imports enter the U.S. via 150 different ports. Although FDA inspectors review100 percent of the entry documents, they physically inspect less than one percent of the total.

In order to supplement this activity, the FDA has a series of mechanisms for dealing with this potentially huge gap. As you may remember earlier this year, Baxter underwent major quality control issues with Heparin that had been supplied via a U.S. supplier through their own Chinese source. These mechanisms include:

• Memos of Understanding (MOUs): the FDA has negotiated more than 50 MOU's with foreign governments that export life science-related products to the U.S. These MOUs cover U.S. standards that the exported products must meet.
• Inspections: the FDA runs more than 1,000 inspections outside the U.S. each year of facilities that export products to the U.S. (food, medications, and other critical, regulated products). These products must all meet good manufacturing practices (GMP).
• Training: the FDA trains officials in other countries to help with inspections.
• Harmonization of guidelines: the FDA is actually leading efforts with its European and Japanese counterparts to harmonize regulatory guidelines for:
  • New Drugs (International Conference on Harmonization).
  • Medical Devices (Global Harmonization Task Force).
  • Veterinary Medications (Veterinary Conference on Harmonization).
• Mutual Recognition Agreements: this is where the FDA relies on its European counterparts to inspect European manufacturing plants that are exporting products to the U.S. on behalf of the U.S.

FDA window dressing?

The latest edition of Genetic Engineering News (Sept. 1, 2008) updates the FDA press release of earlier this year saying that in October, 2008, the FDA plans to open up its new office in China. In lieu of the heparin scare of earlier this year as well as other product safety issues (toys, pet food, tooth paste, etc.), the GEN article raises the point that the FDA action might be possibly just window dressing for the U.S. public. After all, what can 13 people do in a country of 1.2 billion? These 13 persons will be further supported by U.S. personnel.

According to GEN, the FDA conducted last year 332 inspections (versus 260 in 2004) of manufacturing facilities and capabilities to produce safe, high-quality products. The FDA has set a goal of 500 inspections for 2009. In India, there are more than 70 FDA-approved manufacturing facilities exporting products to the U.S.

The FDA has established its “Beyond Our Borders Initiative” which will establish offices not only in China, but also in India, Europe, Latin America, and the Middle East (most likely Amman, Jordan). According to the publication BioPharm International in its Sept. 1 edition, the FDA received an additional $20 million in supplemental budget appropriations in June this year, and this new international action group will have 35 U.S. employees and 13 foreign nationals by the end of next year.

India is the next target with offices to be set up in New Delhi and Mumbai. A Central American operation will focus on large amounts of fruits and vegetables shipped to the U.S.

This raises the question: is the U.S. in reality becoming the world's prevailing regulatory authority for healthcare-related products? Europeans will most likely bristle at this suggestion. The Japanese, also, may not agree with this concept, but the practical reality is that the Japanese FDA, Koseisho, has already moved in the last 10 years to accept both a lot of U.S. (and European) clinical data (although this data was looked at, Japanese regulations previously demanded complete clinical studies in Japanese subjects).

I can remember back in my years working in Latin America, where most regulatory authorities in countries throughout the region would base most of the approval on a U.S. FDA regulatory dossier with only minor local data

With the pharmaceutical, medical device, diagnostic, veterinary product, and even food market becoming increasingly globalized, can the U.S. - even with all of the above actions - effectively police these products around the world with this meager staff? Probably not! The FDA will need to work diligently with foreign regulatory authorities to further train them to higher standards and create effective “harmonized” regulatory structure. There will be a day in the very near future when a mostly global regulatory package submission can be made for a new drug, or medical device. This will save companies, large and small, enormous time and dollars in developing new products.

Tough regulatory environs

Having said all this, the FDA has increased its scrutiny and approval times on drug safety due to the increase in number of drug adverse effects, to the point where lower numbers of drugs are approved each year. This has created a tough environment for both biotech and pharma companies.

Nevertheless, it will be interesting to see how this new FDA international division unfolds.

September 17, 2008