Social Media and Device Reviews: FDA Releases Draft Guidances on Social Media Usage

The U.S. Food and Drug Administration (FDA) has released two long-awaited draft guidances for how medical device and pharmaceutical companies should discuss their products online and, in particular, on social media.

“These documents strive to ensure that the information provided by drug and device companies is accurate and will help patients to make well-informed decisions in consultation with their health care providers,” wrote Thomas Abrams, director of the FDA’s Office of Prescription Drug Promotion on the FDA’s blog.

The first guidance provides recommendations for the presentation of risk and benefit information for prescription drugs or medical devices using Internet/social media sources with character space limitations, such as Twitter and the paid search results links on Google and Yahoo. These recommendations address the presentation of both benefit information and risk information in this setting.

“We understand that communicating on electronic Internet sites with character space limitations can be challenging,” Abrams said. “But, no matter the Internet source used, benefit claims in product promotions should be balanced with risk information. And companies should provide a way for consumers to gain direct access to a more complete discussion of risks associated with their products.”

This guidance gives detailed examples on the use of Twitter, which is limiting as it allows only 140 characters per message. The document acknowledges these limitations, but makes assertions such as if a product is mentioned with one benefit, at least the most severe risk also should be mentioned in the same marketing message regardless of the length limitations.

The second guidance provides recommendations to companies that choose to correct third-party information related to their own prescription drugs and medical devices. This draft guidance provides FDA’s recommendations on the correction of misinformation from independent third parties on the Internet and through social media sites.

“For example, we recommend that any corrections should address all misinformation in a clearly defined portion of a forum on the Internet or social media, whether the misinformation is positive or negative,” Abrams said.

The second guidance gives numerous examples of situations in which companies should or should not correct misinformation. The agency does not intend to monitor companies’ efforts to correct misinformation disseminated online, but suggests that companies keep good records on every instance of misinformation and corrective actions.

Updated Plan to Improve Device Review Procedures
The U.S. Food and Drug Administration (FDA) has released a detailed plan to improve medical device review procedures within the Center for Devices and Radiological Health (CDRH) based on recommendations from an outside auditor’s report issued late last year.

The FDA intends to implement a two-stage process to address four major recommendations of a report released by consultants Booz Allen Hamilton (BAH) in December 2013. To meet those recommendations,the firm advised the FDA to establish more consistency in decision-making, ramp up its training programs and address quality management issues to make the review process more transparent and standardized for reviewers and the companies undergoing review.

“A recurring issue that was identified during our analyses was inconsistent decision-making throughout various stages of the review process, in particular a lack of transparency in thresholds or requirements used to trigger AI (additional information) requests,” Booz Allen’s report states. “In addition, industry stakeholders reported inconsistencies between reviewers referencing outdated guidance during submission reviews, as well as reviewers referencing new standards that were not yet finalized at the time of original submission. Development of tools, criteria and/or mechanisms for assessing and ensuring the consistency of review processes would help ameliorate this issue.”

Booz Allen initially identified 31 “unique” issues related to the device submission review process. The consulting firm concluded that CDRH officials had taken steps to address 21 of those 31 issues, either through the development and implementation of new Medical Device User Fee Amendment (MDUFA) III provisions, updated systems, and/or processes for review staff—and that the division had begun to address another nine of the issues. Only one issue—creating the tools and metrics to assess the consistency of decision-making across the program—remained, and it was the driver for one of the contractor’s high-priority recommendations, CDRH Director Jeffrey Shuren, M.D., said in a blog.

After the December report came out, the CDRH put together its own plan to implement the Booz Allen recommendations. Its strategy calls for:

• Developing criteria and establishing mechanisms to improve consistency in decision-making throughout the review process;
• Providing mandatory full staff training for the three primary information technology systems that support MDUFA III reviews;
• Identifying metrics and incorporating methods to better assess review process training satisfaction, learning and staff behavior changes; and
• Adopting a holistic, multi-pronged approach to address five quality component areas to standardize process life-cycle management activities and improve consistency of reviews. This approach addresses such topics as corrective and preventive action and continuous process improvement, resource management, document management and system evaluation.

The action plan is divided into two stages. The first includes those actions needed to address specific recommendations identified in the December report, most of which will be implemented by 2016. The second stage covers longer-term actions to further enhance the efficiency of CDRH processes beyond what the contractor recommended. “We will now begin to execute this action plan. In addition, we will now develop an implementation plan for the new recommendations in this final report,”Shuren wrote in the blog.

The Advanced Medical Technology Association (AdvaMed) commended the FDA for drafting a detailed plan to implement Booz Allen’s recommendations and said it will particularly monitor the CDRH’s progress on optimizing the center’s refuse-to-accept process.

“An increasing number of 510(k) submissions are being denied by the agency under this process, and we believe it could benefit from more consistent implementation by FDA as well as additional information to sponsors on the administrative requirements for 510(k)s,” Janet Trunzo, senior executive vice president, technology and regulatory affairs, for AdvaMed, said. “We are pleased that the report’s recommendations support the association’s long-held priorities on the need to improve the consistency in decision-making throughout FDA’s review process and to enhance reviewer training and management oversight within the agency’s device center.”

“Of the seven new recommendations in BAH’s report, AdvaMed is particularly supportive of the proposal to analyze the root cause of withdrawn submissions and to develop mechanisms to reduce their occurrence. While we have seen some improvement in total review times in recent years, the percentage of withdrawn submissions remains unacceptably high,” Trunzo concluded.

Senate Confirms New HHS Secretary
On May 5, the U.S. Senate confirmed Sylvia Mathews Burwell as the 22nd secretary of the U.S. Department of Health and Human Services (HHS). Burwell has been the White House’s budget director for the past year. The bipartisan vote was 78-17.

U.S. Senate Finance Committee Chairman Ron Wyden (D-Ore.), whose committee recommended Burwell to the full Senate, said Burwell attracted “a choir of bipartisan support” because “she is really that good, she is really that capable, and she is really that qualified.”

Burwell, a veteran of the Clinton administration’s economic team, will oversee 11 agencies that make up HHS, including the U.S. Food and Drug Administration, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Centers for Medicare and Medicaid Services.

Burwell replaces Kathleen Sebelius, former governor of Kansas, who resigned in April following the troubled rollout of the Affordable Care Act-mandated insurance marketplaces.

A total of 24 Republicans joined all voting members of the Senate’s Democratic caucus in supporting Burwell. Still, the vote was more divided than a rare unanimous vote 14 months ago when the Senate confirmed her to direct the Office of Management and Budget.

Before returning to Washington last year, Burwell spent more than a decade in the world of philanthropy—first with the Bill and Melinda Gates Foundation and then as president of the Walmart Foundation.

AdvaMed Opens Office in China
Officials with the Washington, D.C.,-based Advanced Medical Technology Association (AdvaMed) confirmed that Chinese authorities have approved the trade group’s application to open a representative office in Shanghai, where many AdvaMed corporate members have their China headquarters.

“This official recognition will substantially enhance AdvaMed’s ability to partner with Chinese authorities and other stakeholders, and provide AdvaMed members expanded opportunities to engage on important policy issues in one of the world’s fastest growing markets for medical technology,” said Stephen J. Ubl, president and CEO of AdvaMed.

Key policy issues in China include the need to streamline regulations, ensure appropriate reimbursement for medical technologies and harmonize ethical business practices, according to Ubl. “Our efforts in China will help ensure patient access to advanced medical technologies and will benefit both local Chinese companies and importers,” Ubl added.

AdvaMed’s official recognition in China adds to the association’s existing presence in the country.
Lynn Jiao, executive director of AdvaMed’s China program, has been working on behalf of the association’s members for the past 18 months. Jiao has more than 20 years of experience in China advocating on behalf of medical technology, including as the lead official responsible for medical devices in the U.S. Department of Commerce’s Foreign Commercial Service.

AdvaMed also has established a China Council, consisting of member companies’ senior representatives in the country, which met for the first time in April 2013. In addition, AdvaMed has had a shared staff position with the American Chamber of Commerce in Beijing since 2009.

“Official approval of our China office further solidifies our commitment to this important market, where many of our members have made substantial investments and established research facilities that contribute to China’s growth,” said Ralph F. Ives, AdvaMed executive vice president, global strategy and analysis, said in prepared remarks. “Advanced medical technologies hold great potential to improve patient outcomes, control burgeoning healthcare costs and boost the efficiency of China’s healthcare system. Our new China office will enhance our ability to make our case with local officials and other stakeholders.”