Senators Again Urge FDA to Provide Stronger Warnings on E-Cigarettes

U.S. Senators Barbara Boxer (D-Cal.), Dick Durbin (D-Ill.), Richard Blumenthal (D-Conn.), Jack Reed (D-R.I.), Sherrod Brown (D-Ohio), and Edward Markey (D-Mass.) have again written the FDA Commissioner Margaret Hamburg asking the agency to (1) move quickly to finalize its proposed deeming regulations that would expand the FDA’s regulatory authority over e-cigarettes (see E-cigarette regulations would ban sales to minors, require health warnings, April 25, 2014), and (2) further strengthen the health warnings on e-cigarettes. On August 6, 2014, they previously asked the FDA to move quickly to finalize its proposed rule on e-cigarettes, and to include provisions that would limit youth access to the addictive products (see Congressional plea to FDA: regulate e-cigarette sales to minors now, August 6, 2014).

The FDA’s proposed label warning for e-cigarettes currently reads “WARNING: This product contains nicotine derived from tobacco. Nicotine is an addictive chemical.” With regard to this proposed warning, the Senators’ state “We support requiring a label on nicotine’s addictive properties, but we ask the FDA pursue requirements for more extensive warnings that address health risks that e-cigarettes pose.”

New York Times Article

In their letter, the Senators cite a recent New York Times article which indicates that in the absence of FDA standards, e-cigarette manufacturers are concocting their own health warnings that lack conformity and do not comprehensively list all of the health threats of e-cigarettes. According to the New York Times article, tobacco companies are attempting to position themselves as “protectors of consumer well-being” by providing very strong health warnings on their e-cigarettes, going much further than the warnings they provide on traditional cigarettes.

For example, the Times article quotes a warning provided by the manufacturer of Camel cigarettes, Reynolds American, which warns that their e-cigarette product is not intended for persons “who have an unstable heart condition, high blood pressure, or diabetes; or persons who are at risk for heart disease or are taking medicine for depression or asthma.”

Apparently another manufacturer has gone even farther. According to the article, the warning label on MarkTen e-cigarettes goes on for over 100 words and warns that children, people with heart disease, high blood pressure or diabetes should not use the product. It also warns that nicotine can cause dizziness, nausea, stomach pains, and may worsen asthma.

World Health Organization (WHO)

The Times article also cites a WHO report that concludes because “e-cigarettes and similar devices are frequently marketed by manufacturers as aids to quit smoking, or as healthier alternatives to tobacco, [they] require global regulation in the interest of public health.” According to the WHO report, e-cigarette regulations are needed to: (1) impede e-cigarette promotion to non-smokers and young people; (2) minimize potential health risks to e-cigarette users and nonusers; (3) prohibit unproven health claims about e-cigarettes; and (4) protect existing tobacco control efforts from commercial and other vested interests of the tobacco industry.

While the WHO calls for additional research on multiple areas of e-cigarette use, it believes that regulations are required now for advertising and indoor use. The report calls for an appropriate government body to restrict e-cigarette advertising, promotion and sponsorship, to ensure that it does not target youth and non-smokers or people who do not currently use nicotine. In addition, the report recommends that legal steps be taken to end the use of e-cigarettes indoors in public and work places. The report cites evidence suggesting that exhaled e-cigarette aerosol increases the background air level of some toxicants, nicotine and particles.

Response Requested

In their letter to Commissioner Hamburg, the Senators’ request that she respond with details about the actions the FDA is taking to require e-cigarette manufacturers to truly disclose the risks their products pose to consumers.

Is Early Stage Medical Device Development Going Overseas?

Even though the FDA has recently proposed a new program to provide earlier market access to high-risk medical devices, FDA Commissioner Margaret Hamburg nevertheless came under fire for the agency being to slow to approve medical devices at the annual conference of the Advanced Medical Technology Association (AdvaMed) in Chicago. The implication of her inquisitors was that FDA delays are driving the medical device business to Europe, where device approval standards are more lax. Other health industry research groups disagree, believing that the FDA is acting responsibly, while Europe may be reexamining its lower approval standards.

New Expedited Program

The new FDA program was announced on April 22, 2014, through the issuance of a draft guidance entitled “Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions.” The Expedited Access PMA or EAP program is designed to provide earlier access to high-risk medical devices that are intended to treat or diagnose patients with serious conditions whose medical needs are unmet by current technology and are subject to premarket approval (PMA) applications. The program features earlier and more interactive engagement with FDA staff during device development and more interactive review of investigational device exemption (IDE) applications. The FDA also intends to work interactively with the sponsor to create a data development plan specific to the device.

In addition to the EAP program, the FDA published a separate draft guidance outlining the agency’s policy on when data can be collected after product approval and what actions are available to the FDA if approval condidtions, such as postmarekt data collection, are not met. Entitled “Balancing Premarket and Postmarket Data collection for Devices Subject to Premarket Approval,” the draft guidance also includes advice on the use of surrogate or independent markers to support approval, cimilar to the data points used for accelterated prescription drug approval.

AdvaMed Discussion

In response to reports that slow FDA approvals have sent medical device startups and clinical trials to Europe, Commissioner Hamburg responded (as reported in MedCityNews) that “It’s not a race to who’s first – it’s a race to get the best possible product to people.” Hamburg continued that “approval in Europe doesn’t mean it’s broadly available in the healthcare systems of those countries,” adding that Europe is “in a moment of examination of their regulatory system for devices” due to the emergence of some safety issues.

One example of this “moment of examination” may involve the European Union recall of tens of thousands of defective breast implants. According to an article in Reproductive Health Matters (RHM), “In the U.S., breast implants are regulated as high-risk medical devices that must be proven reasonably safe and effective in clinical trials and subject to government inspection before they can be sold. In contrast, clinical trials and inspections have not been required for breast implants or other implanted devices in the EU; approval is based on other information. As a result of these differing standards, the PIP [Poly Implant Prothese] breast implants that were recalled across Europe had been removed from the market years earlier in the U.S., a decision U.S. government health agencies can point to with pride.”

In an interview with Wolters Kluwer, Diana Zuckerman, PhD, President of the National Center for Health Research, and co-author of the RHM article, indicated she supported Commissioner Hamburg’s position on this issue. According to Zuckerman, recent studies show that devices get on the market in the U.S. about as fast as they do in other countries. In addition, “It is much easier to get insurance coverage for devices in the U.S.  In most other countries, the national health plans won’t pay for devices unless they are proven safe and effective and sometimes need to be proven cost-effective.  In the U.S., such requirements have been  rare.  It is very easy to get devices on the market in Europe and other countries, but difficult to get coverage until studies prove the device’s value.  For that reason, and because devices cost so much more in the U.S. than other countries, device companies are always going to want to sell their products in the U.S.  Whether their headquarters are in the U.S. or not, they need FDA approval to sell in the U.S.  So, that is not going to influence whether a U.S. company moves to another country.”

From a follow-up discussion at the AdvaMed conference, The Boston Globe quotes Mark Deem, managing partner of the medical device startup The Foundry LLC, as stating that “the horse has already left the barn. It’s gotten to the point where entrepreneurs are just moving all their early stage medical device activities lock, stock, and barrel overseas.” With regard to the FDA’s EAP program, MedCityNews further opines that “Deem worries that it has taken so long for the FDA to realize it’s been shellacked by Europeans that it could be too little, too late.” Zuckerman, however, disagrees.  According to Zuckerman, “the decision of some device companies to leave the U.S. is clearly related to the tax advantages of doing so, not related to the FDA approval process or standards for clinical trials in the U.S.”

 Opposition to the EAP Program

Lest anyone think that the FDA’s new EAP program has full support, on July 22, 2014, members of the Patient, Consumer, and Public Health Coalition sent comments to the FDA indicating their lack of support for the program. While the coalition members sympathize with patients who suffer from life threatening or irreversibly debilitating disease, they believe that “the standards for PMA are already substantially lower than for prescription drugs…and yet, the [EAP program] lowers the bar for certain PMA medical devices even further.” The coalition believes “there is no guarantee that the [program] benefits would outweigh the risks for patients.” While the members indicate their support the program’s emphasis on earlier interactive communication between sponsors and the FDA, they also believe the program “gives undue emphasis on postmarket studies that are poorly monitored, have high loss to follow-up, and are rarely conducted in a timely manner that provides useful results.”

Post-Sequester Caps Hamper Control of Infectious Diseases: Sen. Harkin

Senator Tom Harkin (D-Iowa), Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee and the Appropriations Subcommittee on Labor, Health and Human Services and Education has called for an Omnibus bill providing sufficient resources to all federal agencies involved in the control of Ebola and other infectious diseases in the U.S. and overseas. To pay for this, Harkin calls for the lifting the post-sequester caps that return next year when the Murray-Ryan budget deal expires.

Cap Problem

According to Harkin, the post-sequester caps put the government “on autopilot, hampering the work of the [Centers for Disease Control and Prevention] CDC and agencies on the frontlines of controlling Ebola. We must increase resources for CDC, not just to continue their work in the three countries most affected, but also to ramp up surveillance in the 11 countries surrounding the outbreak.”

More CDCs Needed

Harkin believes that every country needs a CDC and that the U.S. must help them develop their own. To that end, Harkin has championed the National Public Health Institutes (NPHI), which currently helps five countries around the world increase surveillance and laboratory and outbreak response capacity to improve the detection of public health threats. Harkin wants NPHI funding increased to expand the program to all 24 of the countries that wish to participate, including 11 in Africa.

CDC’s Role in NPHI

Through leadership and direct engagement with Ministry of Health officials, CDC and partners help countries develop a strategic plan aligned with public health priorities, determine necessary policy changes, create a sustainability plan, and execute a project which includes linking NPHIs with other established NPHIs or U.S. State Health Departments that can provide additional public health expertise. CDC’s role in NPHI emphasizes: (1) high impact investments to maximize an NPHI’s self-reliance; (2) the leveraging of existing partnerships; and (3) the sharing of scientific expertise through a time-limited engagement of 3 to 5 years.

On the Homefront

According to Sen. Lamar Alexander (R-Tenn.) “we must take the deadly, dangerous threat of Ebola in West Africa as seriously as we take the ISIS threat in the Middle East. The spread of this disease requires a more urgent response from the U.S. and other countries.”Alexander urges President Obama to immediately: (1) begin screening at all U.S. airports any person who is traveling to the U.S. from one of the countries with an Ebola epidemic; and (2) designate a single cabinet member to coordinate the response among the agencies involved and the other countries of the world. The U.S. screening would be in addition to any screening received when they leave the country of outbreak.

Harkin believes that in the U.S. we need to: (1) better train doctors in what to look for; (2) strengthen our quarantine stations at the 20 busiest entry-points to the U.S.; (4) fund basic research for better future treatments; and (4) fund clinical trials for potential vaccines and therapies that are currently in the pipeline now.

Malfunction of CMS’ Meaningful Use Attestation Website Causes Concern

Only days after a bill to alleviate Meaningful Use program penalties was introduced in the House of Representatives, a malfunction of CMS’ Meaningful Use Registration and Attestation website has reportedly caused further problems for health care providers attempting to register before the October 1, 2014 deadline.

Legislation

On Tuesday, September 16, 2014, Congresswoman Renee Ellmers (R-NC) introduced “The Flexibility in Health IT Reporting (Flex-IT) Act of 2014” (H.R. 5481). The Flex-IT Act would ensure that health care providers receive the flexibility they need to successfully comply with HHS’ Electronic Health Record (EHR) Incentive Program by allowing them to report their Health IT upgrades in 2015 through a 90-day reporting period as opposed to a full year.

Meaningful Use Program

The $30 billion EHR Incentive Program was established by CMS to encourage physicians and hospitals to switch from paper records to EHRs. The program requires providers to show they are improving health care delivery with “meaningful use” of EHRs and systems. While most Medicare providers have installed the electronic systems, beginning in 2015, those who have not will be penalized with reduced reimbursement.

Malfunction

On August 29, 2014, CMS published a final rule that allows physicians to show they are meeting the program’s goals with older versions of EHR software, if they can prove they have done so by October 1, 2014 (see CMS Final Rule bends timelines and standards for Certified EHR technology, September 2, 2014). Physicians, however, that have attempted to attest to meaningful use on CMS’ Registration and Attestation website have been informed that the website is inoperable and will not be functional until mid-October. That means they will be unable to meet the October 1 deadline, and CMS may withhold 1.0 percent of their 2015 Medicare payments.

Congressional Concern

On September 19, 2014, Ellmers and Jim Matheson (R-Utah) jointly sent a letter to CMS Administrator Marilyn Tavenner expressing their concern that these providers may be penalized, even though they are acting in good faith to meet CMS deadlines. The letter states: “We hope this oversight can be quickly and effectively addressed by CMS. As such, we request an administrative delay in the October 1, 2014, deadline for those attempting to attest for the first time in 2014. Furthermore, we urge you to take immediate action by shortening the 2015 EHR reporting period to 90 days. In light of the respite your agency granted itself, it is only fair to afford the nation’s healthcare providers with equal flexibility to meet the Stage 2 requirements.”

CMS has not yet issued a formal response to the malfunctioning website or the letter.