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Holcombe’s E&C Testimony: PDUFA VI Will Take Patient-focused Drug Development to New Level

March 23, 2017 – In testimony before the House Energy and Commerce Committee’s Subcommittee on Health yesterday, Biotechnology Industry Organization ... read more

Gottlieb Is “Known” Entity to Pharma Industry

March 20, 2017 – Although medical marketers are very familiar with Scott Gottlieb, President Donald Trump’s choice for the top ... read more

Industry Groups Oppose Oregon Bill Calling for Advertising Price Disclosure

March 9, 2017 – Four major advertising and media industry groups have issued a joint letter opposing an Oregon bill ... read more

Trump Needs to Take a Closer Look at FDA Performance

March 8, 2017 – In an open letter to President Donald Trump, Pharmalot’s Ed Silverman asks that before Trump criticizes ... read more

Industry Peacekeeping with President Trump Holds Promise But Portends Danger

By John Kamp, Executive Director, Coalition for Healthcare Communication [Editor’s Note: This “The Final Word” column appeared in the February ... read more

Citizen Petition Calls on FDA to Stay Final Rule Establishing “Totality of the Evidence” Standard for Intended Use

Feb. 24, 2017 – The FDA recently published a final rule on intended use and adequate directions for use that ... read more

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Holcombe’s E&C Testimony: PDUFA VI Will Take Patient-focused Drug Development to New Level

March 23, 2017 – In testimony before the House Energy and Commerce Committee’s Subcommittee on Health yesterday, Biotechnology Industry Organization Senior Vice President of Science Policy Kay Holcombe praised the success of industry user fees paid to the FDA to improve the drug review process and called on the subcommittee to reauthorize the Prescription Drug User Fee Act (PDUFA).

“Kay Holcombe is one of the unsung heroes of the PDUFA process, having represented FDA, Congress and now BIO across the history of this program,” said Coalition for Healthcare Communication Executive Director John Kamp. “We’re pleased that she is a featured speaker at the Coalition Rising Leaders meeting in D.C. on May 16 and can help us more fully understand PDUFA’s critical role in the FDA’s medical approval processes.”

“PDUFA VI builds on the proven premise that greater and more productive interaction between drug developers and FDA works,” Holcombe said. “It leads to better outcomes and to more efficient development programs.”

Holcombe reminded the subcommittee – which was instrumental in the 21st Century Cures Act legislation – that PDUFA VI, which needs to be reauthorized before its expiration in September 2017, “will take patient-focused drug development to a new level.”

According to Holcombe, “PDUFA VI will bring that patient voice to the forefront, changing it from a voice with a compelling story to a voice that provides evidence – verifiable, valid evidence that is appropriate for the drug label.”

She explained that “the message of those commitments is that the patient voice truly matters – in the beginning, when early studies show a promising treatment, and at the end, when FDA is making its decision about a product’s benefit and risk.” She added that “the vision of PDUFA VI is the vision of 21st Century Cures – put patient needs first.”

Further, predictable drug review and drug development timelines are integral to the livelihood of the biotechnology industry, Holcombe stated, because “predictability is critical for companies making investment decisions.” Although that predictability currently exists for drug review under PDUFA V, PDUFA VI would encourage greater predictability and transformation in the drug development arena by expanding expertise in diverse statistical methods, piloting innovative clinical trial designs and computer modeling and simulation, using biomarkers as surrogate endpoints, and utilizing real-world evidence/”big data.”

Holcombe also emphasized the importance of allowing the FDA to hire and retain the people it needs to carry out its PDUFA goals, even with a federal hiring freeze in place, because PDUFA is a carefully negotiated agreement that allocates the majority of user fee costs to FDA personnel. “In PDUFA VI, the annual hiring goals are included in the agreement,” according to Holcombe. “This allows the public a line of sight into whether goals may fall by the wayside as a result of an inability to hire. If this were to happen, fees could not be spent.”

To the relief of many FDA watchers, FDA recently received word from the White House that the federal hiring freeze would not apply to positions funded by industry user fees.

Responding to a question about the possible consequences of Congressional failure to pass PDUFA VI by early summer, Holcombe responded: “Titanic.” Delayed reauthorization would cause hundreds of FDA medical reviewers and other staff to be laid off, she said, crippling the drug review process.

To hear more from Holcombe, attend the Coalition for Healthcare Communication’s Rising Leaders Conference, to be held May 15-16 in Washington, D.C. Holcombe will be speaking on a panel of experts on the FDA, which will be moderated by Coalition Executive Director John Kamp. Joining them on the panel will be APCO Worldwide’s Wayne Pines, an FDA expert on crisis communication and medical marketing and also an FDA veteran; and Mit Spears, former General Counsel of both PhRMA and the Federal Trade Commission, who is on several lists for a senior policy position in the Trump administration. For more information or to register, contact John Kamp at jkamp@cohealthcom.org.

Gottlieb Is “Known” Entity to Pharma Industry

March 20, 2017 – Although medical marketers are very familiar with Scott Gottlieb, President Donald Trump’s choice for the top job at the FDA and a former FDA deputy commissioner for medical and scientific affairs, they can only make educated guesses about how he will run the agency of 14,000 people and what his positions will be regarding FDA regulation and policy. Gottlieb, a physician, beat out venture capitalist Jim O’Neill, who was backed by Trump crony Peter Thiel, for the nomination, which must be approved by the Senate.

Gottlieb currently is a resident fellow at the American Enterprise Institute, has opposed many FDA regulations during his career, and has close ties to industry, which likely will come up as concerns at his Senate confirmation hearings but could ultimately benefit drug makers.

APCO Worldwide’s Wayne Pines told the Coalition for Healthcare Communication that “Scott is an excellent choice for FDA. He is familiar with the agency and its culture and mission. He understands not only the issues but also the challenges that FDA faces. I think his immediate challenges are to assure that FDA has adequate funding, and that FDA recruits and hires the staff it needs to understand and review new medical technologies and to facilitate the enactment of the user fee legislation.”

“The two most important issues for medical marketers are drug approvals and marketing policy,” noted Coalition Executive Director John Kamp. “Gottlieb is good news on both counts. Gottlieb and CDER Director Janet Woodcock are longtime colleagues and good friends, having occupied adjoining office suites as deputies for former FDA Commissioner Andrew von Eschenbach,” Kamp continued. “The two will work hand-in-hand in any reforms of the drug approval process. At the same time, Gottlieb has been a critic of current FDA regulation of off-label communication and is likely to address the issues around it sooner rather than later during his tenure.”

According to Scientific American, “Gottlieb praised the 21st Century Cures Act (which was signed into law in December 2016), and said that it would help smooth the way for quicker approvals by zeroing in on results from small trials and interim study results instead of waiting for more traditional clinical trial findings.” Gottlieb also has supported streamlining efforts to bring generic drugs to the market faster.

A March 10 article in Forbes, to which Gottlieb has been a frequent contributor, states that his writings in the publication “reveal the sharp mind of a man who doesn’t believe the system is fundamentally broken, but who is distrustful of bureaucracy as a solution and attuned to the way that small policy changes can have outside effects.”

Further, Pines commented that Gottlieb “understands the importance of gaining the confidence of the professional staff at FDA and I’m sure he’ll be able to do that successfully.”

For the very best of educated guesses on what to expect from the Gottlieb-led FDA, don’t miss the FDA expert panel at the Coalition for Healthcare Communication Rising Leaders meeting, held on May 15 and 16 in Washington, D.C. The panel, moderated by Kamp, includes three preeminent experts on FDA matters:

  • Kay Holcombe, BIO lobbyist and Hill and FDA veteran, who has helped negotiate virtually all the PDUFA bills passed to fund the FDA;
  • APCO Worldwide’s Pines, FDA expert on crisis communication and medical marketing, also an FDA veteran; and
  • Mit Spears, former General Counsel of both PhRMA and the Federal Trade Commission, who is on several lists for a senior policy position in the Trump administration.

If usual Congressional confirmation timing holds, Gottlieb’s Senate confirmation hearing will be scheduled near the time of the Rising Leaders meeting.

Register now for the Coalition’s Rising Leaders conference. The event begins with dinner on May 15, featuring former Commissioner Robert Califf as the dinner speaker, and continues the next day with a wide array of inside-the-beltway experts on medical policy issues. Contact John Kamp for registration and further information at: jkamp@cohealthcom.org.

Industry Groups Oppose Oregon Bill Calling for Advertising Price Disclosure

March 9, 2017 – Four major advertising and media industry groups have issued a joint letter opposing an Oregon bill (S.B. 792) that would require manufacturers to disclose prescription drug wholesale prices in any ads run in the state or face potential civil penalties of up to $5,000 per ad publication or broadcast.

According to the March 8 letter to Oregon senators from the Association of National Advertisers (ANA), the American Association of Advertising Agencies (4A’s), the American Advertising Federation (AAF) and the Coalition for Healthcare Communication, prescription drug product advertising already is heavily regulated by the FDA and direct-to-consumer (DTC) advertising “may be the most heavily regulated business category in our entire economy.”

“The Coalition and its allies are watching closely for such proposals in the states,” said Coalition Executive Director John Kamp. “While the Trump administration promises to reduce government regulation on business, the states can be expected to fill the gaps.”

The joint letter (oppose-senate-bill-792-2) states that by mandating that all DTC advertising in the Oregon disclose the wholesale price paid by pharmacies or the manufacturer’s list price for the product, the Oregon bill violates both the First Amendment because of content-based restrictions and the Interstate Commerce clause of the U.S. Constitution because of the state-specific disclosure. “The legislation creates a substantial disincentive for pharmaceutical companies to provide valuable information to consumers,” the groups assert.

They also cite a concern that this proposed legislation would set “a very dangerous precedent for a wide range of products and services that become ‘controversial,’” and that as a result, marketers “could face threats from more than 30,000 state and local governments that seek to mandate specific disclosures in their ads.”

“This legislation would be particularly pernicious because it would leave medicine marketers with only two choices: (1) create new ads for Oregon; or (2) just skip the state altogether,” according to Kamp. “The former would increase substantially the cost of advertising in Oregon, and the latter would decrease the information available to Oregon professionals and patients.”

To view the bill, go to: https://olis.leg.state.or.us/liz/2017R1/Downloads/MeasureDocument/SB792/Introduced

Trump Needs to Take a Closer Look at FDA Performance

March 8, 2017 – In an open letter to President Donald Trump, Pharmalot’s Ed Silverman asks that before Trump criticizes and plans any reform of the Food and Drug Administration (FDA), he should take a hard look at how the agency has performed in recent years.

“During the past decade, the FDA has increasingly used various tactics to speed approvals of medicines that work in new ways. Last year, 73 percent of the so-called novel drugs were approved using programs such as fast track or breakthrough designations, up from 66 percent in 2014,” Silverman wrote in a March 6 post.

“And here are more figures to consider: Between 2003 and 2010, 23 cancer drugs were approved by both the FDA and European Medicines Agency, but the median review time by the FDA was 182 days — compared with the 350 days taken by European regulators,” he noted.

Silverman called out Trump for pointing to a woman with Pompe disease during his address to Congress and saying that the FDA “keeps too many advances, like the one that saved [her] life, from reaching those in need,” when in fact, the drug in question was approved in nine months after a clinical trial of just 39 patients. “That’s hardly an example of slow and burdensome,” Silverman stated.

He cited other statistics and examples in support of the FDA’s strong performance, and stated that any notion of Trump appointing crony Peter Thiel’s friend Jim O’Neill to the FDA Commissioner position, when O’Neill has no medical background, is “reckless.”

“Your sound bites may appeal to anyone frustrated with bureaucracy. But if anything is burdensome, it is your misguided notion of improving public health,” according to Silverman.

To read the full post, go to: https://www.statnews.com/2017/03/06/trump-fda-misguided/

Industry Peacekeeping with President Trump Holds Promise But Portends Danger

By John Kamp, Executive Director, Coalition for Healthcare Communication

[Editor’s Note: This “The Final Word” column appeared in the February 2017 edition of MedAdNews and is reprinted with permission.]

As a public official preparing for international negotiations, I was taught by the U.S. State Department to always know exactly what you want and what you’re willing to give up before sitting down with a skilled international trading partner. It looks like pharma representatives may have been well prepared recently when sitting down with the country’s new Negotiator-In-Chief, Donald Trump.

With news media cameras rolling, President Trump opened the meeting by reiterating his position against drug prices and demanding that more drugs be produced in the United States. But, he moved quickly to offer lower taxes and government deregulation as trade offs. Indeed, in the private meeting that followed, he seem to backtrack on campaign pledges to require government negotiation of prices, “re importation” of drugs from other countries while promising a new FDA Commissioner who will deliver a “streamlined” agency with faster drug reviews.

“You people are going to do great,” Trump reportedly told the CEOs.

It all sounds like a reasonable bargain for the industry, but skilled negotiators also know that the devil is in the details, and lots of details are yet to be known about the new Trump/pharma industry deal.

Among other things, the continued drug price criticism will likely ensure Congressional bipartisan attacks on pricing and thus and increase the chances that drug marketing could be caught in the crossfire.

Even the President’s carrots may turn out to stick the industry where it hurts, if recent events are an indication of what’s to come.

Two recent executive orders and leaks about who might be appointed as head of the FDA have increased the anxiety of industry watchers on the future of drug approvals and the new rules needed to advance the goals of the recently passed 21st Century Cures Act.

The two orders have rattled the industry are: (1) the freeze on federal hiring and (2) the requirement that two rules be rescinded for every new one created.

The FDA policy and approval processes are implemented by its staff, and because the FDA has hundreds of vacancies in the Center for Drug Evaluation and Review (CDER), the hiring freeze is especially troublesome. Indeed, it is not even clear if the freeze applies to new hires paid for by industry fees. Freezing hiring will chill approvals and the development of new policies intended to simplify and speed all activities at the agency.

Meanwhile, the two-for-one rule is particularly complicated at the FDA, where hundreds of policy decisions are announced through informal guidances that, according to White House representatives, are within the scope of the order.

Most unnerving to FDA insiders and industry policy veterans are the names of some of the possible nominees to be Commissioner of the FDA.

As many of you know, Dr. Robert Califf resigned on inauguration day and has been replaced on an interim basis with Dr. Stephen Ostroff. At the CEO meeting, Trump promised to quickly appoint a “fantastic person” to be the agency’s permanent head.

Four names have been mentioned for FDA Commissioner. All have been involved in healthcare startups, investments, and private-sector innovation which may be a good sign, but several have ideas viewed as extreme by industry.

Two of the possible candidates are friends of Peter Thiel, Silicon Valley billionaire supporter of Trump, but lack the usual medical credentials. The first is Jim O’Neill, managing director of Mithril Capital Management, former deputy at HHS who has openly favored a multiple-step approval system under which drugs would first be approved for safety only. The second friend of Thiel is Balaji Srinivasan, partner at Andreessen Horowitz and CEO of 21.co who is a fierce opponent of the current device approval process.

The other two potential choices are doctors. Joseph Gulfo, former CEO of device company Mela Sciences is an outspoken opponent of the breakthrough approval process and favors a new evidence standard for approval. Scott Gottlieb, former FDA deputy commissioner, is a high-profile advocate for improvements at FDA and is the inside-the-Beltway favorite because of his experience at FDA and in lower-volatility positions.

In the face of all this, CDER head Janet Woodcock recently produced a staff video suggesting employees keep their heads down and focus on the work of the agency rather than on the uncertainty of the transition. Good luck with that, Dr. Woodcock.

Meanwhile, the tax reductions promised by Trump may include a mixed bag for the publishers and medical agency members of our industry. To come anywhere close to the oft-promised low teen corporate tax rate preferred by industry, several traditional and significant tax deductions will have to be reduced or eliminated.

One such deduction sure to be in that discussion is for the cost of marketing. While I will be writing more on this soon, know that the Congressional Budget office has estimated that reductions in the tax deductibility of advertising could raise $169 Billion over ten years. That’s just too big a number to be ignored in the tax negotiations.

Meanwhile, Sen. Al Franken (D-MN) has recently renewed his interest in targeting medical marketing by eliminating its deductibility. While the Ad Tax Coalition recently suppressed that proposal, we’re certain to see it again and again as Franken seeks Republican support for the measure.

So, while the pharma CEOs clearly seem ahead of the negotiation game for now, there are lots of details yet to be settled. Whether those details turn out to be devils or angels remains to be seen.

Citizen Petition Calls on FDA to Stay Final Rule Establishing “Totality of the Evidence” Standard for Intended Use

Feb. 24, 2017 – The FDA recently published a final rule on intended use and adequate directions for use that establishes a not-previously-announced “totality of the evidence” standard and is in violation of the Administrative Procedures Act because it deprives stakeholders of fair notice and the opportunity to comment, according to a Feb. 8 citizen petition.

The petition, filed on behalf of the Medical Information Working Group (MIWG), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO), follows the Jan. 9 publication of the FDA final rule, which the petitioners claim “dramatically shifted gears” from the proposed rule on the matter issued in September 2015 and, as such, “should be stayed indefinitely and reconsidered for two independent reasons.”

The first reason listed in the petition is that the final rule violated the fair notice requirements of the APA because it changed the definition of intended use by introducing a new, and overly broad totality of the evidence standard that is not found in the Food, Drug and Cosmetic Act, and by allowing FDA to consider any evidence, including knowledge, to determine intended use and adequate labeling, which were not even “hinted at in FDA’s proposed rule.”

“Stakeholders surely would have challenged FDA’s decision to use a ‘totality’ approach as an FDCA linchpin,” the petition states, due to concerns that “overbreadth and vagueness take on special weight where, as here, FDA is purporting to define the scope of its own jurisdiction.” Further, petitioners argue that the approach endorsed by the final rule “would allow qui tam relators and prosecutors to predicate claims or charges against manufacturers on the entirely legitimate activity of accurately forecasting demand for its products,” including approved and unapproved uses, “and then scaling production to meet that demand.”

The second reason that the final rule should be stayed, according to the petition, is that the totality standard is “a new and unjustified legal standard.” Although the FDA argues in the final rule preamble that the totality standard is supported by case law and does not represent a change in the law or the agency’s practices, “these arguments lack merit,” the petition states.

The final rule “is attempting to codify a highly controversial standard that is inconsistent with the statute and case law and has never been subjected to public scrutiny,” it asserts, adding that this standard “also raises serious constitutional questions.”

“In the final hours of the Obama administration, FDA likely made two mistakes on this final rule, one that is focused on legal issues and one that is focused on policy issues,” according to Coalition for Healthcare Communication Executive Director John Kamp.

“On the legal side, the FDA did not give the public sufficient notice that it was moving to a ‘totality of the evidence’ standard. While it can change its rules, FDA simply must give interested parties notice and opportunity to comment before creating a new rule,” Kamp said. “On the policy side, the industry petitioners likely are correct that new standard is sufficiently broad and vague for plaintiff’s lawyers to have a heyday bringing questionable lawsuits against industry.”

Along these lines, the petition states that under the final rule standard, “no one will be able to know, in advance, what evidence … a prosecutor might consider sufficient to deem an actual use to be an intended use, raising significant Fifth Amendment concerns,” and notes that this ambiguity will have a chilling effect on valuable scientific speech that “is difficult to overstate.”

“The off-label issue is just too important to the public health and too sensitive to First Amendment challenges for this final rule to stand,” Kamp said. “I suspect when new leadership arrives at FDA, the final rule will be reviewed and revised.”

OPDP Plans Just One Guidance Document for 2017

Feb. 20, 2017 – Although the FDA announced last August that it would issue four advertising-related guidance documents by the end of 2016, the Office of Prescription Drug Promotion (OPDP) fell short of that goal and apparently will set a very low bar for 2017: It plans to issue only one guidance document in 2017.

According to the Center for Drug Evaluation and Research (CDER) Guidance Agenda for 2017 issued Feb. 17, CDER has committed to issuing a guidance document entitled “Drug and Device Manufacturer Communications with Payors, Formulary Committees and Similar Entities.” The agency announced a draft guidance on this topic on Jan. 19, so it appears OPDP would plan to issue a final guidance on this matter at some point after the comment period on the draft document ends April 19.

This recent announcement leaves in limbo the much-awaited guidance document on off-label/unapproved uses, which industry has been promised for years. The agency held a two-day forum on this issue last November and recently extended the comment period on the topic until April 10; however, without that topic appearing on the guidance agenda for 2017, it remains to be seen whether the agency will act on this topic any time soon.

The Trump administration’s call for regulatory agencies to delete two regulations for every new regulation (which may include guidance documents) could be affecting the agency’s projected plans for 2017 guidance documents. That said, efforts to answer industry’s requests for more guidance on off-label use surely have stalled beyond reasonable expectations.

However, Coalition for Healthcare Communication Executive Director John Kamp noted that “It’s important to not take this report too seriously. New leadership is coming to FDA. The Trump crew will have its own agenda that will likely take hold quickly.”

FDA Appears Subject to Some Exemptions from Hiring Freeze

Feb. 13, 2017 – A memo sent to Department of Health and Human Services (HHS) division heads last week from HHS Acting Deputy Secretary Colleen Barros attempts to better define exemptions from the federal hiring freeze imposed by President Donald Trump on Jan. 23, and may provide some relief to the FDA, which has hundreds of job vacancies.

According to the memo, “a number of position types have been identified as meeting … exemptions from the hiring freeze.” Those specified in the memo include positions that “are deemed necessary to meet national security or public safety responsibilities.”

Under the “Patient Care and Health-related Research” category, the memo specifies that critical positions include “scientific, research, and program-related position that oversee clinical and/or public health programs”; under the “Public Health Safety and Emergencies” category, the memo states that positions that involve preparing for and responding to public health emergencies, such as pandemic influenza, Ebola and the Zika outbreak, are exempt, as are positions that ensure “public health safety through programs such as food, drug and medical device safety” and that respond to national public health emergencies, such as the opioid epidemic.

FDA advisory board members appear to fall under an additional, limited exemption, which states that during the 90-day period that the initial executive order is in place, “appointments will only be considered for those committees that are legally mandated, but not for those that are discretionary.”

The Barros memo follows a Jan. 31 memo from the Office of Management and Budget (OMB) and the Office of Personnel Management which states that exemptions from the hiring freeze are permitted for “filling of positions under programs where limiting the hiring of personnel would conflict with applicable law.” Many have argued that FDA new drug review activities would be included under that exemption.

Indeed, Regulatory Focus reports that Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.) sent a letter to OMB last week asking that it clarify how the freeze specifically impacts the FDA and its ability to implement the 21st Century Cures Act.

“FDA’s ability to carry out numerous new responsibilities under Cures – such as antibiotic approvals, validation of drug development tools, patient focused drug development, and issuance of new guidance – will depend on the agency’s ability to staff up,” the Upton/DeGette letter stated. The lawmakers also asserted in the letter that FDA user fee funds should be made available for hiring.

Kamp: Buckle Up for a Bumpy Ride with Trump

Coalition Commentary by Executive Director John Kamp

Feb. 6, 2017 — Fasten your seatbelts and put your tray tables in their upright and locked position as you watch the Trump administration land on our industry.

At a recent White House meeting with PhRMA and industry CEOs,  Trump made sure the cameras were rolling as he repeated his screed against drug prices and demanded that more drugs be produced in the United States. But, he later followed up by seemingly rescinding calls to negotiate Medicare drug prices and reimportation of drugs from abroad, and promising lower taxes and a “streamlined” FDA. The result is a mixed bag of good and bad for our industry.

Two recent executive orders and leaks about who might be appointed as head of the FDA have increased the anxiety of industry watchers on the future of drug approvals and the new rules needed to advance the goals of the recently passed 21st Century Cures Act.

The two orders that have rattled the industry are: (1) the freeze on federal hiring and (2) the requirement that two rules be rescinded for every new one created.

The FDA policy and approval processes are implemented by its staff, and because the FDA has hundreds of vacancies in the Center for Drug Evaluation and Research (CDER), the hiring freeze is especially troublesome. Indeed, it is not even clear if the freeze applies to new hires paid for by industry fees. A hiring freeze will chill approvals and the development of new policies intended to simplify and speed drug approvals.

Meanwhile, the two-for-one rule is particularly complicated at the FDA, where hundreds of policy decisions are announced through informal guidances that, according to White House representatives, are within the scope of the order.

Most unnerving to FDA insiders and industry policy veterans are the names of some of the possible nominees to be Commissioner of the FDA.

Four names have been mentioned for FDA Commissioner. All have been involved in healthcare startups, investments, and private-sector innovation, which may be a good sign, but several have ideas viewed as extreme by industry.

Two of the possible candidates are friends of Peter Thiel, Silicon Valley billionaire and Trump supporter, but lack the usual medical credentials. The first is Jim O’Neill, managing director of Mithril Capital Management, former deputy at HHS who has openly favored a multiple-step approval system under which drugs would first be approved for safety only. The second friend of Thiel is Balaji Srinivasan, partner at Andreessen Horowitz and CEO of 21.co, who is a fierce opponent of the current device approval process.

The other two potential choices are doctors. Joseph Gulfo, former CEO of device company Mela Sciences, is an outspoken opponent of the breakthrough approval process and favors a new evidence standard for approval. Scott Gottlieb, former FDA deputy commissioner, is a high-profile advocate for improvements at FDA and is the inside-the-Beltway favorite because of his experience at FDA and in lower-volatility positions.

In the face of all this, CDER head Janet Woodcock recently produced a staff video suggesting employees keep their heads down and focus on the work of the agency rather than on the uncertainty of the transition.

Brace yourself and stay tuned. The Trump team comes with high winds and crosscurrents. It looks like it’s coming in hot.

Draft Guidance Covers How to Keep Communications Consistent with FDA Labeling

Jan. 27, 2017 – The FDA issued draft guidance last week that is designed to help medical product  manufacturers understand how the agency evaluates product communications, including promotional materials, that present information not contained in the FDA-required labeling but that may be “consistent with” that labeling.

“We are aware that firms have questions about how FDA determines when such communications are consistent with the FDA-required labeling, and how they are viewed by FDA,” the agency states in the Jan. 19 Federal Register notice announcing the document’s availability.

The notice also states that although a firm’s communications that are consistent with the required labeling will not “alone be considered evidence of a new intended use,” “representations or suggestions made about the product would misbrand the product and could subject forms to enforcement action if [these statements] are false or misleading.”

The question-and-answer format of the draft guidance spells out the following:

  • How the FDA determines whether the communication is consistent with FDA-required product labeling and how the FDA views this communication
  • What types of information are considered consistent with the FDA-required labeling
  • What types of information are not considered consistent with FDA-required labeling
  • What evidentiary support firms should have to support its communications
  • What other considerations apply to communications that are consistent with FDA-required labeling
  • What the FDA recommends firms consider when developing these types of communications so their materials are not considered false or misleading
  • Examples of communications that would be considered inconsistent with FDA-required labeling
  • What the agency’s policies are for communications that are not consistent with FDA-required labeling

The draft guidance also would impose a reporting burden on the industry as part of the “third-party disclosure” recommendations, which call on firms to disclose various aspects of study design and methodology for studies relied upon in order to provide material contextual information. Material limitations related to the study design, methodology design and results “also must be disclosed in a clear and prominent manner to help ensure that the communications are false and not misleading,” and should include disclosure of “unfavorable or inconsistent findings,” the agency states in the notice.

The draft guidance also stipulates that disclosure of material limitations of the study relied upon for communication claims “does not correct the misleading message conveyed by the communication.” The reporting burden for this recommendation is estimated at four hours per disclosure.

“This new disclosure requirement is unnecessary,” according to Coalition for Healthcare Communication Executive Director John Kamp. “I don’t think it will survive in the new administration.”

The FDA is accepting comments on this draft guidance by April 19. To view the document, go to: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537130.pdf