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Kamp Commentary: Pricing Issues Take Center Stage in D.C.

May 23, 2017 — By Coalition for Healthcare Communication Executive Director John Kamp Participants at last week’s Coalition for Healthcare ... read more

Califf Calls for Off-label Promotion Code of Ethics

May 18, 2017 – At this week’s information-packed Coalition for Healthcare Communication’s Rising Leaders Conference, keynote speaker and former FDA ... read more

The Marketing Implications of Tax Reform

By John Kamp, Coalition for Healthcare Communication Executive Director May 11, 2017 – Although no one seems to like the ... read more

Gottlieb Vote Headed to Full Senate

May 1, 2017 – Having cleared the Senate Committee on Health, Education, Labor and Pensions (HELP) with a 14-9 vote ... read more

What Medical Marketers Can Expect from President Trump, Republican-led Congress

April 24, 2017 – There is no doubt that the Trump administration is likely to change health policy, but the ... read more

Kamp: Three Ways Congress Could Suppress DTC or All Medical Marketing

Coalition Commentary by Executive Director John Kamp April 17, 2017 — Agencies, media and clients all need to watch closely ... read more

States Make Moves to Ease, Restrict Medical Communications

March 31, 2017 – With Congress in a seemingly permanent state of gridlock, individual states are taking actions that may ... read more

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Kamp Commentary: Pricing Issues Take Center Stage in D.C.

May 23, 2017 — By Coalition for Healthcare Communication Executive Director John Kamp

Participants at last week’s Coalition for Healthcare Communication Rising Leaders Conference on Healthcare Policy in D.C. heard much about the possibility of price controls on our client’s products but did not find broad consensus on whether they might happen and what form they might take.

The stakes are high, not just for life sciences companies, but also for all types of medical marketers and media. Consider, for example, the recent IMS study of pharma profits in 2016 showing that increased profits did not come from new products but from price increases during that period. If pricing flexibility is constrained, drug company spending on marketing, media and sales support will also follow suit.

Virtually every speaker at the meeting addressed price pressures, from Jon Bigelow, meeting chairman, in his opening, to yours truly near the closing. Although no one would discount the possibility of some controls, the most startling prediction came from the usually restrained voice of Kate Rawson, senior editor at Prevision Policy and the RPM Report.

Rawson reviewed both the multiple, staggering efforts of House Republicans to pass legislation that would “Repeal and Replace” ObamaCare and the difficulties of passing a similar bill in the Senate that would in turn survive a House-Senate Conference committee. She then outlined the many Democratic as well as Republican efforts to reduce drug prices.

Rawson concluded by noting that it may well be easier for Congress to pass bipartisan price control legislation than to garner Republican agreement on ObamaCare. Wouldn’t that be a stunner!

Notably, Mit Spears, formerly general counsel of both the FTC and PhRMA, disagreed, not so much because he believed health care reform would be easy for Republicans, but because there are many ways the administration can lower drug spending without legislation. Indeed, he pointed to several FTC anti-trust tools as well as various HHS/FDA techniques that could reign in pricing (and profitability).

Summarizing this disagreement later, I admitted that I didn’t know which view was correct, but that it may not matter. With or without legislation, pricing pressures are great right now and increasing. Government will do what it will — in Congress, at HHS, at FDA and maybe in a few states — but the public shaming and purchasing pressures that are already working will increase, not decrease, no matter what.

So, there you have it. Lively discussion on the various ways pricing controls may play out, but little disagreement on the bottom line – pricing pressures are here and may well increase. If you missed the conference, you missed the lively give and take, but you can still review the slide decks, available here: (bigelow), (o’brien), (rawson), and (kamp).

Stay tuned on this one. It is an important issue with potentially dire ramifications.

Califf Calls for Off-label Promotion Code of Ethics

May 18, 2017 – At this week’s information-packed Coalition for Healthcare Communication’s Rising Leaders Conference, keynote speaker and former FDA Commissioner Robert Califf said that “healthcare marketers need to create a code of ethics to promote drugs for truthful and non-misleading uses outside their FDA-approved labels, commonly referred to as off-label promotion,” according to coverage of the meeting in MM&M.

“Given the deregulated state [of off-label promotion], you need to come up with a code of ethics,” Califf advised attendees at the Monday session, MM&M reported. “Your efforts should be truthful and non-misleading,” Califf added. “Truthful you get, non-misleading is really hard. It’s like a bad marriage; it’s not what you say. It’s what you didn’t say. The misleading part is where you need to focus.”

To view the full article, go to: http://www.mmm-online.com/legalregulatory/fda-off-label-promotion-califf-marketing-advertising-pharma/article/661852/?DCMP=EMC-MMM_Newsbrief_20170516&cpn=mmmcpn&spMailingID=17241742&spUserID=NzAzNDA1MTY4ODQS1&spJobID=1021335603&spReportId=MTAyMTMzNTYwMwS2

The Marketing Implications of Tax Reform

By John Kamp, Coalition for Healthcare Communication Executive Director

May 11, 2017 – Although no one seems to like the new Trump/Ryan healthcare bill, House staffers now (finally) are preparing for the next big Republican effort – overhauling the tax system for both individuals and corporations. Like healthcare, everyone seems to agree that an overhaul is necessary, but the options for affecting change seem as controversial, scattered and disparate as they are with healthcare reform.

In theory, tax reform is very popular among life sciences companies, especially reductions in the tax rates and repatriation of oversees profits. To get there, the Republican House leaders are calling for a “border tax” on foreign-produced goods and a reduction or elimination of most corporate deductions.

The sketchy Trump plan released recently from the White House calls for a virtually unachievable 15-percent tax rate on corporations (unless the Republicans are willing to accept billions of dollars in deficit spending, a result they routinely abhor, at least during Democratic administrations). Most economists agree that a 15-percent rate (or more likely a rate in the mid-20s) is only achievable with a simultaneous elimination of longstanding tax deductions, including even mortgage interest, state taxes, investment expenses and the like.

Advertising and other marketing costs will be one of the traditional corporate deductions that will be on the auction block to pay for the reduction in the corporate tax rate. So far, while the deduction is in the mix, no tangible plan has emerged, The last time it arose in 2014, then-Congressman Dave Camp (R-Mich.) and former Sen. Max Baucus (D-Mont.) recommended cutting the marketing deduction in half, then deducting one half in the year expended and amortizing the other half over five or 10 years.

The Congressional Budget Office “scored” the Camp/Baucus plan to increase tax income to the government to $169 billion in the first 10 years. Others estimated that it would increase the average cost of marketing by 12 percent in just the first three years after enactment. Raising the cost of advertising reduces its ROI, inevitability reducing its use. The effect on marketing companies and media would be immediate.

Getting to the 15 percent tax-reduction goal likely would require an even sharper cut, the elimination of the deduction altogether. Ouch.

In practice, tax reform is going to be at least as tough, if not tougher, than healthcare. Don’t expect it to be wrapped up this summer as some hopeful Republicans suggest. It will take some time, probably most of the remainder of this year and into 2018.

Unsurprisingly, advertising and media organizations, including the Coalition for Healthcare Communication, will resist the elimination of the deduction. Indeed, the deduction arguably is more important to the ad groups than it is to the advertisers themselves, who desperately want the lower rate. In fact, some in the life sciences would forgo the marketing tax deduction for the lower rate.

Meanwhile, unless and until advertisers tell their organizations, including us, to stand down, the formidable The Advertising Coalition (TAC) will work to defeat the ad tax change. Indeed, TAC just this week is announcing a major effort to defeat the measure even before it is proposed.

At the urging of TAC, a bipartisan group of 124 Members in the U.S. House of Representatives wrote to Speaker Paul Ryan and Minority Leader Nancy Pelosi asking them to preserve the impact of advertising on the economy as Congress considers an overhaul of our nation’s tax laws (april-27-2017-yoder-engel-advertising-tax-deduction-letter-with-signatures2-c-c-c).

This congressional effort, led by Reps. Kevin Yoder (R-Kan.) and Eliot Engel (D-N.Y.), calls on House Leadership to maintain the current tax treatment of advertising as a fully and immediately deductible cost of doing business.

“We are grateful that so many Representatives in Congress have joined in this letter to acknowledge the important role advertising performs in our marketplace today,” Jim Davidson, Executive Director of TAC, said in a May 10 press release (press-release-124-members-of-the-u-s-house-of-representatives-have-signed-april-27-2017-c). “Advertising does so much more than sell goods and services. It keeps our radio stations, newspapers, websites, television and cable broadcasts running and provides open access to information.”

The House letter cited a study by the economic consulting firm IHS Economics and Country Risk, which finds that advertising supported 20 million U.S. jobs and $5.8 trillion in U.S. sales in 2014. The study also demonstrates that every dollar of advertising spending generates $19 of economic activity and that advertising contributes to 19 percent of the nation’s GDP.

The letter was perfectly timed to demonstrate that there is a wall of opposition to a new ad tax just as the discussions heat up in the House of Representatives.

Now the next major skirmish in the House begins. Watch this issue carefully and stand ready to respond to requests from us, through TAC, to communicate to your Member of Congress about the effects of such a tax change on your business. It’s going to be an interesting battle.

Stay tuned.

Gottlieb Vote Headed to Full Senate

May 1, 2017 – Having cleared the Senate Committee on Health, Education, Labor and Pensions (HELP) with a 14-9 vote on April 27, Dr. Scott Gottlieb’s nomination to be the next FDA commissioner is now headed for a full Senate vote. So far, Gottlieb’s nomination has moved quickly and smoothly through the nomination process.

“Gottlieb is a great choice because of his extensive knowledge of both the FDA and the industry,” said Coalition for Healthcare Communication Executive Director John Kamp. “With two assignments at FDA and one at HHS, Scott learned the lore and the inner workings of the agency, and established a reputation with career staff as a leader. On the industry side, he’s worked with numerous small and large companies to learn to stimulate and manage innovation. He understands the difficulties of creating new products, getting them approved at the FDA and having them accepted in the market.”

Although Sen. Patty Murray (D-Wash.) expressed some concerns at the HELP committee hearing about Gottlieb’s ties to industry, Kamp noted that “industry will find him to be a tough regulator who keeps patients and the public health as his highest priorities.”

Two Democratic senators – Sen. Sheldon Whitehouse (R.I.) and Sen. Michael Bennet (Colo.) – joined their Republican fellow committee members in voting for Gottlieb’s nomination to continue on to the full Senate. According to Stat, several senators, including Murray and Sen. Elizabeth Warren (D-Mass.), asked Gottlieb to submit written responses prior to the committee hearing regarding how he would deal with possible reduced funding and staffing levels at the agency.

Industry largely is in favor of Gottlieb’s nomination – he is a medical professional and someone with a great working knowledge of and experience at the FDA. Kamp stated that when it comes to the two most important issues for marketing professionals and their clients – approvals and marketing policy – Gottlieb is supportive of industry’s point of view.

“Gottlieb will work hand in hand with Janet Woodcock to ensure that drugs are approved only when safe and effective, but also at the highest rate possible,” Kamp said. “He has already written about ways to improve the approval policies, especially for new categories where there are unmet needs. I think industry also can expect faster approvals for generic, biosimilar and combination products.”

On the marketing side, Kamp noted that Gottlieb can be expected to speed the development of policies that enable sponsors to communicate scientifically sound off-label information to health professionals. Further, “he will likely encourage the Office of Prescription Drug Promotion to speed up marketing material review times and enable more intense use of new media,” according to Kamp.

The date for a full Senate vote on Gottlieb’s nomination has not yet been set.

What Medical Marketers Can Expect from President Trump, Republican-led Congress

April 24, 2017 – There is no doubt that the Trump administration is likely to change health policy, but the questions that remain to be answered are exactly what those changes will be and how they will affect healthcare communication. If you want predictions and insight from a distinguished panel of FDA and policy experts, register now to attend the Coalition for Healthcare Communication’s Second Annual Rising Leaders Conference on Healthcare Policy, to be held May 15-16 in Washington, D.C.

The Coalition meeting is an information-packed conference designed to provide background and context about key issues facing this industry to the next generation of leaders in healthcare advertising, medical communications, public relations, medical publishing and media, and digital communications.

The program will feature a keynote speaker each day, with former FDA Commissioner Dr. Robert Califf speaking on May 15, and Sen. Chris Murphy (D-Conn.) speaking on May 16. Additional speakers include Prevision Policy Senior Editor Kate Rawson, BIO Senior VP Kay Holcombe, APCO Worldwide President for Healthcare Wayne Pines, attorney and former EVP and General Counsel for PhRMA Mit Spears, and 4A’s EVP for Government Relations Dick O’Brien. A panel of industry experts also will address how knowing what happens in Washington matters to the careers of healthcare communicators.

To review the agenda, go to: 2017_rising_leader_conf_agenda_v3-2. To register, contact John Kamp at jkamp@cohealthcom.org.

Kamp: Three Ways Congress Could Suppress DTC or All Medical Marketing

Coalition Commentary by Executive Director John Kamp

April 17, 2017 — Agencies, media and clients all need to watch closely as this Congress looks to regulate medical manufacturers’ real or perceived excess profits, or at least bring down the cost of medical products for citizens. So far, the political heat on medicine companies has not been focused much on marketing, but instead has been targeting prices and increased transparency. Marketing is mostly a tertiary matter, caught in the crossfire over pricing.

However, you best believe that if pricing and transparency bills come to votes this year, medical marketing will be lumped in among other provisions. Marketing changes, if they come at all, likely will appear in one to three main forms, each with its unique dangers to industry’s bottom lines.

First, consider the direct-to-consumer (DTC) advertising delay bill introduced repeatedly in the House of Representatives by Rosa DeLauro (D-Conn.). DeLauro would not ban DTC, but would disallow it for the first three years after a drug is approved. Although this is not a knock-out punch, it would be a direct hit for launch campaigns, during the critical early years of a drug’s patent-protected period. Such legislation would be vulnerable to a First Amendment court challenge, but it would not be a slam dunk for the industry and could be in litigation for years.

Second, look at the wide-ranging pricing proposals being put forward by a group of Democratic Senators led by Sherrod Brown (D-Ohio) and Al Franken (D-Minn.). Marketing takes a back seat in these proposals to pricing and transparency, but tucked near the end is a familiar provision to eliminate the tax deductibility of DTC advertising.

Watch this one very closely, because although such provisions are termed DTC-only provisions, past versions have been “scored” by the tax specialists in a way that sweeps in the entire marketing spend. If marketing is not tax deductible by manufacturers, the actual costs go up and the return on investment (ROI) goes down. Marketing spend will drop in concert to its ROI. This threat to marketing is the most vulnerable to a First Amendment challenge, but it too could take years of court wrangling to be successfully challenged.

The third danger is tax reform, and the possible elimination of the tax deduction for all marketing that could well be taken up in that larger legislative package. There again, the actual cost of marketing would go up and the ROI down, but not so drastically as with the Brown/Franken plan because it would presumably be paired with a reduction in the overall tax rates for manufacturers, media and agencies.

Broad-spectrum tax legislation cannot be successfully challenged under the First Amendment and may be applauded, not opposed, by clients. Although tax reform is a major priority for the Trump administration and Republican leaders in Congress, expect it to take much longer than predicted.

For much more on these and other challenges to our business, make sure you’re signed up to attend the May 15-16 Coalition Rising Leaders Conference on Healthcare Policy, to be held in Washington, D.C. Hear about tax reform and the pharma industry from 4A’s Executive VP for Government Relations Dick O’Brien, who will parse the content and prospects for various proposals. The program will feature a keynote speaker each day, with former FDA Commissioner Dr. Robert Califf speaking on May 15, and Sen. Chris Murphy (D-Conn.) speaking on May 16. Additional speakers include Prevision Policy Senior Editor Kate Rawson, BIO Senior VP Kay Holcombe, APCO Worldwide President for Healthcare Wayne Pines, and attorney and former EVP and General Counsel for PhRMA Mit Spears. A panel of industry experts also will address how knowing what happens in Washington matters to the careers of healthcare communicators. To register, contact me at jkamp@cohealthcom.org.

Coalition Rising Leaders Conference Helps Medical Marketers Answer Pressing Questions

April 11, 2017 – There is no doubt that the Trump administration is likely to change health policy in the near future, but the questions that remain to be answered are exactly what those changes will be and how they will affect healthcare communication. For predictions and insight from an expert panel of FDA and policy experts, register now to attend the Coalition for Healthcare Communication’s Second Annual Rising Leaders Conference on Healthcare Policy, to be held May 15-16 in Washington, D.C.

The Coalition meeting is an information-packed conference designed to provide background and context about key issues facing this industry to the next generation of leaders in healthcare advertising, medical communications, public relations, medical publishing and media, and digital communications.

The program will feature a keynote speaker each day, with former FDA Commissioner Dr. Robert Califf speaking on May 15, and Sen. Chris Murphy (D-Conn.) speaking on May 16. Additional speakers include Prevision Policy Senior Editor Kate Rawson, BIO Senior VP Kay Holcombe, APCO Worldwide President for Healthcare Wayne Pines, attorney and former EVP and General Counsel for PhRMA Mit Spears, and 4A’s EVP for Government Relations Dick O’Brien. A panel of industry experts also will address how knowing what happens in Washington matters to the careers of healthcare communicators.

For program details, go to: 2017_rising_leader_conf_agenda. To register, contact John Kamp at jkamp@cohealthcom.org.

States Make Moves to Ease, Restrict Medical Communications

March 31, 2017 – With Congress in a seemingly permanent state of gridlock, individual states are taking actions that may affect how companies can communicate about their products within state borders. Arizona will soon become the first state to allow industry to communicate truthful off-label information about its products; Vermont has introduced a resolution calling for legislation “to rein in” direct-to-consumer (DTC) advertising.

Arizona’s “The Free Speech in Medicine Act” (HB 2382), signed into law March 21 and effective in 90 days, establishes that medical product companies and their representatives “may engage in truthful promotion of an off-label use of a drug, biological product or device.” Further, the state may not prosecute companies or their representatives for doing so.

The Arizona bill was based on model language provided by Christina Sandefur, executive vice president of the Goldwater Institute, who said in a March 22 statement that “curbing the exchange of information about off-label treatments by those with the most knowledge about the drug’s uses, risks and side effects not only prevents patients from receiving the best possible care; it violates the constitutional right to free speech.” The Goldwater Institute previously campaigned for “Right to Try” laws to give patients access to experimental treatments; 33 states have adopted these provisions.

“The Goldwater Institute and Arizona clearly have the policy right,” said Coalition for Healthcare Communication Executive Director John Kamp. “Truthful off-label information from drug sponsors helps doctors and patients know what is needed to make appropriate treatment decisions.” However, Kamp pointed out that according to the law of preemption, “these are FDA, not state, policy decisions.  I’m optimistic that the new Gottlieb-led FDA will create rules that make such information sharing the law of the land.”

Earlier this year, Vermont passed a joint resolution (JRS 19) asserting that drug companies spend “on average, twice as much on advertising and marketing as they do on research and development,” and stating that “one of the significant factors contributing to the increasing costs of prescription drugs is the growth of direct consumer promotional campaigns sponsored by the nation’s pharmaceutical companies through print, broadcast, and Internet media.”

The resolution also claims that drug companies’ DTC ads have “the potential to lure a lay person into accepting the positive claims and ignoring the less prominently promoted and possibly dangerous side effects” in spite of these ads being regulated by the FDA. With new leadership at the agency, “The time to rein in direct advertising of prescription drugs to consumers clearly has arrived,” the resolution states.

Specifically, the Vermont resolution seeks legislation that would, among other provisions, restrain drug company expenditures on advertising and marketing, and place a moratorium on DTC promotion while the FDA develops “more effective regulations” of that practice.

“The Vermont resolution, like similar proposals by Sen. Al Franken (D-Minn.), is based on faulty reasoning and bad communication policy,” Kamp said. “Consumer and professional promotion of medicines informs doctors and patients of innovative new options available that often cure or mitigate disease. Suppressing information is bad policy and a violation of the First Amendment.”

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.