Angie Drakulich was editorial director of Pharmaceutical Technology.

Angie Drakulich

The FDA plans to hold a public hearing to discuss the promotion of agency-regulated drugs and medical devices using the internet and social media tools. 

"The continually evolving nature of the Internet, including Web 2.0 and social media tools, as well as their expansion to applications such as mobile technology, have raised questions and concerns over how to apply existing regulations to promotion in these newer media," states the notice. "FDA is evaluating how the statutory provisions, regulations, and policies concerning advertising and promotional labeling should be applied to product-related information on the internet and newer technologies. Although the agency believes that many issues can be addressed through existing FDA regulations, special characteristics of Web 2.0 and other emerging technologies may require the agency to provide additional guidance to the industry on how the regulations should be applied."

The meeting, scheduled for 1213 November in Washington (US), is a collaboration among the FDA’s Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Veterinary Medicine(CVM), and the Center for Devices and Radiological Health (CDRH). 

The FDA invites public participation, as well as written comments, on this issue to help in the decision-making process for policies that regulate online and social media promotions.  

The agency held a similar public meeting in 1996 when the internet was becoming popular. Since that time, blogs, microblogs, podcasts, online communities, video-sharing, Wikis and more have emerged. Specific topics at the meeting will address, among other things:

For what online communications are manufacturers, packers, or distributorsaccountable? 

How can manufacturers, packers, or distributors fulfill regulatoryrequirements? 

What parameters should apply to the posting of corrective information on Web sites controlled by third parties? 

And questions specific to internet adverse-event reporting. 

 Comments for the meeting can be submitted by 9 October 2009 and after the meeting until 28 February 2010 at 

. Registration information to attend the meeting is included in the full 

Articles

The FDA plans to hold a public hearing to discuss the promotion of agency-regulated drugs and medical devices using the internet and social media tools.

FDA to hold public hearing on online drug promotion

The US Food and Drug Administration plans to hold a public hearing to discuss the promotion of agency-regulated drugs and medical devices on the Internet and using social media tools, according to a notice in the Sept. 21, 2009, 

. The meeting is a collaboration among FDA’s Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Veterinary Medicine (CVM), and the Center for Devices and Radiological Health (CDRH). The meeting is scheduled for Nov. 12–13, 2009 in Washington, DC.
  
“The continually evolving nature of the Internet, including Web 2.0 and social media tools, as well as their expansion to applications such as mobile technology, have raised questions and concerns over how to apply existing regulations to promotion in these newer media,” states the notice. “ FDA is evaluating how the statutory provisions, regulations, and policies concerning advertising and promotional labeling should be applied to product-related information on the Internet and newer technologies. Although the agency believes that many issues can be addressed through existing FDA regulations, special characteristics of Web 2.0 and other emerging technologies may require the agency to provide additional guidance to the industry on how the regulations should be applied.”
  
 FDA invites public participation, as well as written comments, on this issue to help in the decision-making process for policies that regulate online and social media promotions. 
  
The agency held a similar public meeting in 1996 when the Internet was becoming popular. Since that time, blogs, microblogs, podcasts, online communities, video-sharing, Wikis, and more have emerged. Specific topics at the meeting will address, among other things:

   For what online communications are manufacturers, packers, or distributors
 accountable?

How can manufacturers, packers, or distributors fulfill regulatory
 requirements?

 What parameters should apply to the posting of corrective information on Web sites controlled by third parties?

  And questions specific to Internet adverse-event reporting.

  Comments for the meeting can be submitted by Oct. 9, 2009, and after the meeting until Feb. 28, 2010, to 

The US Food and Drug Administration plans to hold a public hearing to discuss the promotion of agency-regulated drugs and medical devices on the Internet and using social media tools, according to a notice in the Sept. 21, 2009, Federal Register.

FDA to Hold Public Hearing on Online Drug Promotion

Speaking to the audience of the 2009 PDAFDA Joint Regulatory Conference in Washington (USA), this week, the FDA's Principal Deputy Commissioner, Joshua M. Sharfstein, outlined four principles that define the FDA's role as a public health agency. He and FDA Commissioner Margaret Hamburg introduced their concept of FDA as a public health agency in a May 2009 

The first principle of public health is prevention, Sharfstein told the conference audience. Referring to an earlier talk by Rick Friedman, Director of the FDA Division of Manufacturing & Product Quality, he noted recent challenges in the pharmaceutical industry, including supply-chain management and the adulteration of drug products with contaminants such as diethylene glycol. "I think all of these things are amenable to a preventive approach," he said. "When one company falters because of a quality problem, it’s their problem to fix and prevent. But when a problem occurs across the industry, when it causes the kind of quality-system problems…it’s everyone’s problem and it’s FDA’s problem to help think about solutions."

Sharfstein also brought up the quality trio guidelines finalized by the International Conference on Harmonization, ICH Q8, Q9, and Q10, as an example of how industry can prevent problems. "The goal of these efforts is to understand from the start what makes a product of high quality rather than waiting to discover a problem after the fact," he said. "[FDA] would like to foster more such productive collaboration that leads to concrete results in preventing problems."

The second principle of a public health approach identified by Sharftstein during his talk is the "best available science". He noted that FDA is working to identify key projects that can help product quality, streamline approval pathways and improve scientific training. "We’d like to see more guidance documents emerge out of these scientific efforts to provide a clear and transparent process to address long-standing quality issues and to help bring important products to the market."

Third, a public agency by definition involves the public, he said, pointing to the new transparency initiatives at FDA such as its website, public meetings and 

. He encouraged industry to improve its transparency as well, noting that sometimes, companies are reluctant to issue a press release or conduct a recall when things go wrong.

"In the next decade, with speed of information only accelerating, it's a good assumption that product quality problems will eventually come to light. It's better for companies to develop effective and transparent communication systems now rather than stumble when others are providing key messages about your products for you," he said.

Sharfstein emphasized his point by stating, "When public health is at stake, FDA is going to take this basic position: You can explain this problem to the public or we will." This statement likely refers to the agency's new enforcement plan, which went into effect on 15 September (

Fourth and finally, Sharfstein discussed the premise of public health as one in which the health of the public matters. "In evaluating product quality issues for 2020, I would imagine there are many ways to resolve key challenges as you face them, however, I urge you to consider the health of the public as the North Pole for your compass."

In some concluding remarks during a question-and-answer session, he added: "Let’s not be so risk-averse that we lose opportunities for really important innovation and progress."

After introducing the concept of the FDA as a public health agency earlier this year with FDA Commissioner Margaret Hamburg, the FDA's Principal Deputy Commissioner, Joshua M. Sharfstein, has now outlined four principles that define the agency's role.

FDA assumes role of public health agency

Speaking to the audience of the 2009 PDA–FDA Joint Regulatory Conference in Washington, DC, this week, US Food and Drug Administration Principal Deputy Commissioner Joshua Sharfstein outlined four principles that define FDA’s role as a public health agency. He and FDA Commissioner Margaret Hamburg introduced their concept of FDA as a public health agency in a May 2009 

  The first principle of public health is prevention, Sharfstein told the conference audience. Referring to an earlier talk by Rick Friedman, Director of the FDA Division of Manufacturing & Product Quality, he noted recent challenges in the pharmaceutical industry, including supply-chain management and the adulteration of drug products with contaminants such as diethylene glycol. “I think all of these things are amenable to a preventive approach,” he said. “When one company falters because of a quality problem, it’s their problem to fix and prevent. But when a problem occurs across the industry, when it causes the kind of quality-system problems…it’s everyone’s problem and it’s FDA’s problem to help think about solutions.”  

  Sharfstein also brought up the quality trio guidelines finalized by the International Conference on Harmonization, ICH Q8, Q9, and Q10, as an example of how industry can prevent problems. “The goal of these efforts is to understand from the start what makes a product of high quality rather than waiting to discover a problem after the fact,” he said. “[FDA] would like to foster more such productive collaboration that leads to concrete results in preventing problems.”

  The second principle of a public-health approach identified by Sharftstein during his talk is the “best available science.” He noted that FDA is working to identify key projects that can help product quality, streamline approval pathways, and improve scientific training. “We’d like to see more guidance documents emerge out of these scientific efforts to provide a clear and transparent process to address long-standing quality issues and to help bring important products to the market.”

  Third, a public agency by definition involves the public, he said, pointing to the new transparency initiatives at FDA such as its website, public meetings, and 

“In the next decade, with speed of information only accelerating, it’s a good assumption that product quality problems will eventually come to light. It’s better for companies to develop effective and transparent communication systems now rather than stumble when others are providing key messages about your products for you,” he said.

  Sharfstein emphasized his point by stating, “When public health is at stake, FDA is going to take this basic position: You can explain this problem to the public or we will.” This statement likely refers to the agency’s new 

  Fourth and finally, Sharfstein discussed the premise of public health as one in which the health of the public matters. “In evaluating product quality issues for 2020, I would imagine there are many ways to resolve key challenges as you face them, however, I urge you to consider the health of the public as the North Pole for your compass.”

  In some concluding remarks during a question-and-answer session, he added, “Let’s not be so risk-averse that we lose opportunities for really important innovation and progress.”

Speaking to the audience of the 2009 PDA-FDA Joint Regulatory Conference in Washington, DC, this week, US Food and Drug Administration Principal Deputy Commissioner outlined four principles that define FDA's role as a public health agency.

FDA's Sharfstein Outlines Principles of Public Health Agency

The 2009 PDA-FDA Joint Regulatory Conference opened this morning in Washington, DC, with a keynote address by Dr. Joshua Sharfstein, principal deputy commissioner at the US Food and Drug Administration.

FDA's Sharfstein Addresses Industry

The FDA plans to begin collecting information for its Sentinel Initiative, according to 

 announcement. The initiative, established in May 2008, focuses on enabling the agency to improve the monitoring of drug performance after marketing approval by working with multiple healthcare data systems. The 2007 FDA Amendments Act calls for the agency to access data from 25 million patients by July 2010 and from 100 million patients by July 2012, according to the announcement. 

"The proposed system will enable queries of distributed data sources quickly and securely for relevant product safety information," says the announcement. "Data will continue to be managed by its owners and only data of organizations who agree to participate in this system will be included."

The call for data, which will help the FDA plan for this proposed system and for future work related to the Sentinel Initiative, has been submitted for approval to the Office for Management and Budget. The data sought includes the scope, content, structure, quality, and timeliness of data; patient population(s), duration of followup, and capture of care across all settings; availability, experience and interest of investigators with knowledge of the data in using it for postmarket product safety surveillance as well as plans for further data source enhancements; availability, experience, and interest of investigators with knowledge of the data in participating in a distributed data system; and barriers that exist to including each data source in the Sentinel Initiative. 

The agency estimates that each respondent submitting the above information will spend approximately 24.5 hours doing so. The FDA expects 250 respondents to participate in the survey. 

The FDA plans to begin collecting information for its Sentinel Initiative, according to Federal Register announcement.