US Legislators Target Number of Regulatory Programs in 2013 Workflow

The US House of Representatives' Energy and Commerce Committee, the legislative body charged with overseeing the US Food and Drug Administration (FDA), has released its planned workflow for the year, including a number of programs likely to affect regulatory professionals.

Core Regulatory Programs

The committee is broadly involved with healthcare, and was instrumental in passing the 2012 FDA Safety and Innovation Act (FDASIA), which reauthorized and created a number of user fee programs and FDA reforms.

In a document entitled, "Oversight Plan for the Committee on Energy and Commerce," legislators explained that they plan to "Review whether FDA is ensuring that regulated drugs are safe, effective and available to American patients in an expeditious fashion."

"The Committee will also explore the interplay between these policies and drug innovation, both in the United States and abroad," it said. "Further, the Committee will examine FDA's enforcement of current drug safety laws and the issues involved in protecting the nation's supply chains against economically motivated and other forms of adulteration."

To this latter point, the committee has authorized FDA to collect user fees from generic pharmaceutical companies with the goal of increasing the number of regulatory inspections it conducts abroad. The agency is involved in a number of other regulatory initiatives, the majority of which are being coordinated through its Office of International Programs (OIP) or its Office of Regulatory Affairs (ORA).

Legislators also said they plan to continue an investigation into how FDA handled a fungal meningitis outbreak resulting from quality failures at a Massachusetts-based compounding facility. The committee has already threatened to subpoena FDA if it does not turn over documents the committee requested regarding the agency's regulatory history with the New England Compounding Center (NECC), the company now thought to be behind the meningitis outbreak that has killed dozens and made ill hundreds more.

Non-Core Regulatory Programs

Also to be assessed in 2013 are the capabilities of public health agencies to respond to pandemics and epidemics, including influenza. The House recently approved the Pandemic and All-Hazards Preparedness Reauthorization Act (PAPRA), which would reauthorize money used to beef up product development, develop new regulatory pathways, and give FDA regulators the authority to conduct emergency reviews and approvals during public health emergencies.

Other aspects could also come to affect regulated operations. The committee said it plans to "Explore the state of manufacturing in the US to identify factors that are hampering or further US competitiveness," including globalization, production networks, manufacturing networks, and the integrity of products manufactured abroad. Such issues regularly come up in discussions about globalized manufacturing of component drug parts, such as active pharmaceutical ingredients, and whether regulators are adequately able to oversee those operations relative to ones conducted in the US. Often, those discussions conclude that US manufacturers are at a comparative disadvantage to their foreign-based counterparts, which are seen as being inspected less often.

Other programs to be assessed include:

• The BioWatch program, which acts like a giant medical device network intended to provide early warning capabilities in the case of a biological attack.
• The oversight of high-containment biosafety level facilities, which are often used to conduct research on products eligible for the animal rule pathway, including those intended to treat Anthrax.
• The securing of chemical manufacturing facilities as part of the Chemical Facilities Anti-Terrorism Program.
• The US Department of Health and Human Services' (DHHS) National Toxicology Progam (NTP), which assesses which chemicals are fit or not fit to be used in products such as vaccines or pharmaceuticals.