Update: FDA Globalization Act Discussion Draft Revised

August 4, 2008

Representative John Dingell (D-MI) has revised several of the drug-related sections of the Discussion Draft of the FDA Globalization Act (“FDAGA”).  We first reported on the Discussion Draft, which has received significant attention from industry and stakeholder groups alike, in April 2008. 

Updated sections of the FDAGA were recently posted on the U.S. House of Representatives’ Energy and Commerce Committee’s website.  The updated draft does not significantly alter any sections of the original Discussion Draft, but it does include several new provisions of interest – many of which appear to be aimed at ensuring the purity of drugs.  Several of the new additions are blank placeholders left for further updating. 

First, the updated draft calls for inspections of drug, active ingredient, device, and device part manufacturing establishments every two years.  However, FDA can permit inspections once every four years if such a timeline would be appropriate when considering the class of the products, associated risks of the products, shipping volume, the history of the facility, and any other factors the Agency finds relevant.  The draft discussion also adds a section calling for reports to Congress on “the risk-based process for conducting surveillance of 8 current good manufacturing practices” under FDC Act § 510(h)(4). 

The revisions also include several sections on risk management.  If these revisions are enacted, the FDC Act would be amended to hold that a drug is adulterated if it is manufactured in a plant that fails to have a risk management plan.  The risk management plan must “provide for an assessment, prior to contracting with a person to supply raw materials or ingredients . . . of the suitability and competence of such person to carry out such activity,” explain the quality control process, “provide for the monitoring and review through periodic on-site audits of the facility,” “provide for the monitoring of incoming materials,” and explain quality control measures to ensure that the drugs manufactured are pure.  FDA would have authority to inspect this risk management plan during facility inspections.   

In addition, the updated draft adds a requirement for the documentation of the supply chain for all steps in the chain of drug manufacturing.  Each establishment registered with FDA must also be able to provide the Agency with an electronic statement that documents the chain of supply for the drug. 

Several other provisions are aimed at giving FDA greater authority.  For example, the revised Draft Discussion contains sections that would give FDA greater recall authority.  Perhaps to alert FDA to the need for a recall, a provision was added that requires that a person, other than a consumer, who “has reason to believe that a drug intended for human use would cause serious, adverse health consequences or death, shall” notify FDA as soon as practical of the danger.  The bill, if enacted, would require penalties for those who manufacture counterfeit drugs and provides for greater civil penalties for those who violate the FDC Act (although the actual dollar amounts of the penalties were mostly left blank). 

Finally, the end of the updated draft contains two very interesting additions.  First is a blank section titled “FDA Bonuses.”  Text below this heading indicates that the language will be added later.  Rep. Dingell has been a vocal critic of FDA bonuses and has launched an investigation into the Agency’s compensation practices.  Second is a section stating that FDA has “extraterritorial Federal jurisdiction over any violation of this Act relating to any food, drug, device, or cosmetic intended for import into the United States.”  It remains to be seen what, if anything, will be added to or deleted from these sections.    

Although the latest revisions to the FDAGA Draft Discussion are not extensive, they do indicate that the bill continues to receive the attention of Rep. Dingell and others in Congress.  We will continue to monitor this legislation and report on any further updates. 

By Susan J. Matthees