A Bigger, Bolder FDAGA

By Ricardo Carvajal & Susan J. Matthees –      

The FDA Globalization Act (“FDAGA”) of 2008 was “meant to stimulate discussion about how to provide adequate funding and authority for FDA to ensure safety” of products over which the agency has jurisdiction.  When we commented on that proposed legislation, we couldn’t help but make special mention of the many fees that were included.  FDAGA 2009 brings back the fees, and adds a number of new authorities – and responsibilities – for FDA and for industry.  Below we summarize some of the principal changes that are not fee-related.

FDAGA 2008 proposed several new requirements and authorities applicable to foods, including establishment of a food safety plan, safety standards for fresh produce, periodic inspections, certification of facilities and accreditation of laboratories, and mandatory notification and recall, among others.  FDAGA 2009 retains these and adds others, including:

• All facilities would be required to develop and implement a HACCP plan (conduct a hazard analysis, implement preventive controls, monitor effectiveness of those controls, and keep records).
• FDA’s access to records would be significantly strengthened, perhaps finally putting to rest the decades-long debate over the extent of FDA’s authority to access records during a food inspection. In addition, farms and restaurants would be subject to recordkeeping requirements.
• FDA’s administrative detention authority would be significantly strengthened.
• Some of the violations that were previously categorized as “prohibited acts” (e.g., failure to register or pay fees) would now render a food misbranded.
• Making false statements to a facility or laboratory certifying agent would be a prohibited act.
 
Many of these provisions (as well as those carried over from FDAGA 2008) would require FDA to issue implementing regulations or guidance, for which tight timeframes are provided.  It is not clear whether the costs of doing so would be covered by the fees that would be raised under FDAGA.  In addition, the Department of Health and Human Services (“HHS”) is tasked with taking numerous additional measures to improve surveillance and understanding of food borne illness.  If those efforts meet with success, they could result in greater capabilities to link outbreaks to specific foods, thereby helping to overcome one of the historic obstacles to successful product liability actions in the food arena – that of establishing causation.  Finally, we couldn’t help but notice that FDAGA 2009 requires HHS to conduct research to “develop methods to reduce or destroy pathogens before, during, and after processing.”  Unfortunately, getting those methods approved by FDA is another matter, as illustrated by the ongoing difficulties in getting irradiation technologies to market.
 
The sections of FDAGA 2008 that pertained to drugs included provisions for FDA inspections of manufacturing facilities, requirements for risk management plans, detailed supply chain requirements, greater recall authority for FDA, country of origin labeling, and requirements for testing of purity and identity for drug products.  The drug section of FDAGA 2009 retains many of these same provisions and includes others, such as: 
 
• Failure to pay registration fees would render a drug misbranded, but FDAGA 2009 exempts orphan drugs and certain not-for-profit medical centers from paying registration fees and allows for a waiver or reduction of fees for drugs that are necessary for public health or where the fee would be a financial hardship for the company. 
• New inspection requirements call for drug facilities to be inspected every 2 years unless the Secretary determines that once every 4 years would be sufficient. 
• No personal use exemption from the requirement that imported drugs have information demonstrating compliance with FDA requirements. 
• A drug is misbranded if the manufacturer’s Website does not list the country of origin of the active pharmaceutical ingredients and finished dosage form of the drug. 
• New “voluntary” procedures for manufacturers to follow for a recall.
 
As with the food section of FDAGA, many of the provisions in the drug section would require FDA to issue regulations or guidance.
 
FDAGA 2008 proposed several new requirements for cosmetic products, including good manufacturing practice and adverse event reporting requirements.  FDAGA 2009 retains these, expands some of them, and adds a few new ones.  Of particular interest:
 
• FDAGA 2009 retains the requirement that cosmetic manufacturers register and adds more detailed registration requirements, including annual registration of both foreign and domestic facilities and  the requirement that the Secretary keep a list of registered establishments.
• Cosmetic companies will be required to submit an ingredient list for every cosmetic manufactured. 
• More comprehensive requirements for adverse event reporting

Finally, for those of you who have been following the bouncing ball on preemption, section 2 of FDAGA 2009 makes clear that no preemption of state law is intended.

FDAGA 2008 proposed several new requirements for cosmetic products, including good manufacturing practice and adverse event reporting requirements.  FDAGA 2009 retains these, expands some of them, and adds a few new ones.  Of particular interest:

• FDAGA 2009 retains the requirement that cosmetic manufacturers register and adds more detailed registration requirements, including a requirement for annual registration of both foreign and domestic facilities and a requirement that the Secretary keep a list of registered establishments.
• Cosmetic companies will be required to submit an ingredient list for every cosmetic manufactured. 
• More comprehensive requirements for adverse event reporting

Finally, for those of you who have been following the bouncing ball on preemption, section 2 of FDAGA 2009 makes clear that no preemption of state law is intended.