PharmExec Blog

A Blueprint for FDA Reform

The FDA five-year strategy emphasizes a more coordinated—and skeptical—response to globalization of the drug supply chain. On balance, the strategy continues to focus more on managing risk than assessing benefit—industry take heed.

Earlier this month, FDA released a five-year, forward-looking strategic priorities report—“Responding to the Public Health Challenges of the 21st Century”—that outlines what the industry plans to accomplish between now and 2015. “It’s no secret that FDA’s responsibilities have increased significantly over the past several years,” says the report. “We will address these challenges and aim to fulfill our mission by embracing innovation and actively pursuing partnerships with federal, state, and local agencies; international authorities; academia; non-government organizations; and the private sector.”

Five key priorities are discussed in the report:

1. Advance Regulatory and Science Innovation

The report defines regulatory science as “the science of developing new tools, standards, and approaches to assess the safety, effectiveness, quality, and performance of FDA-regulated products.”

“Recent innovative breakthroughs in science and technology … have the potential to transform our ability to prevent, diagnose, and treat disease,” reads the report. Such advancements could lead to more personalized medicine, while advances in research and information technologies can lead to more successful preventive health initiatives.

The report calls for a “robust regulatory science program” and recognizes that FDA needs to foster innovation and actively participate in research initiatives. FDA will focus on implementing a plan “for expanding and modernizing the field of regulatory science within the agency,” so that regulatory science does not fall behind the rate of medical innovation.

2. Strengthen the Safety and Integrity of the Global Supply Chain

The rapid increase of globalization has raised new challenges for the industry and for FDA. Among those challenges, according to the report, are: increasing volume and complexity of imported products; a patchwork of foreign, federal, and state oversight of product safety, grater opportunities for fraud; greater risk of national security threats; and a lack of accountability at any one stop on the supply chain. An increase of contaminated foods and other international scares have served as sufficient warning and “forced FDA to reevaluate its approach to supply-chain safety,” according to the report. “The growing challenges of globalization have far outstripped the FDA’s resources for inspection and quality monitoring, and the inability to maintain adequate oversight means potential risk to consumers grows every year.”

The solution, according to FDA, is to focus on prevention of globalization-related problems, by requiring more information about supply-chains and closer monitoring throughout a product’s life cycle. The report calls for closer collaboration on the foreign, federal, and state levels, including a new “global alliance of regulators” that would provide early indicators of supply chain threats and problems.

3. Strengthen Compliance and Enforcement Activities to Support Public Health

“FDA enforcement actions affect not only the manufacturing and distribution of food, drugs, biologics, medical devices, tobacco, and cosmetics, but also their development and marketing,” says the report. “Enhancing FDA’s compliance and enforcement programs will strengthen the agency’s focus on preventing problems and responding rapidly when violations occur.”

Deadlines for industry to respond to significant inspection findings; new processes to prioritize follow-up inspections; and FDA’s criminal enforcement program which deters non-compliance, all go a long way in supporting public health. But long before a product reaches consumers, safe manufacture and delivery are essential as well. To that end, the report says that FDA will work more closely with regulatory authorities on the local and state level, to “enable faster identification of threats to the public health and quicker response times … to reduce the likelihood of harmful products being manufactured and distributed.”

4. Expand Efforts to Meet the Needs of Special Populations

FDA addresses here the underrepresentation in clinical trials of certain populations, including women, minorities, and the pediatric population. Because of this, the report claims, “Questions regarding effectiveness, pediatric dosing, and side effects for drugs often go unanswered.”

FDA plans to combat these problems by collaborating with the EU, Japan, Australia, and Canada in efforts to ensure that children are “enrolled in scientifically and ethically sound trials”; advancing women’s health through grants and increased research efforts; overcoming language barriers to make health information available to the target population; and through the recent creation of a new Office of Minority Health.

5. Advanced Medical Countermeasures and Emergency Preparedness

“Despite considerable financial and human resource investments since [September 11] 2001, the United States does not yet have the range of medical countermeasures (MCMs) it requires to … respond to a deliberate chemical, biological, radiological, or nuclear event or naturally occurring infectious disease outbreaks,” states the report. Because of complex regulatory concerns and slow time-to-market, there are currently very few FDA-approved MCMs available to respond to such a threat, and they can’t quickly be made once a threat is discovered (think vaccines for HINI, for instance).

Consequently, FDA has created an MCM Action Plan that involves enhancing the regulatory review process for MCMs; advancing regulatory science for MCM development and evaluation; and optimizing the legal, regulatory, and policy framework for effective public health response. In addition, says the report, “FDA remains committed to advancing its emergency preparedness and response capabilities.”

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One Comment

  1. Tita Beal
    Posted April 28, 2011 at 10:56 am | Permalink

    The regulations are crucial now that many pharmas are setting up plants around the world. We can make sure the plants we set up are safe… but it will be difficult to check how the vendors to our plants operate. Rather than pressuring the FDA to appreciate our value, I hope the industry will partner with the FDA to figure out how to manage safety in a global industry – as many top pharmas do now. (I worked pfor one of them and was impressed with the commitment throughout the organization not just to compliance but also to helping the FDA and the US Ag Dept to develop scientifically valid regs when needed.)

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