On a panel titled “Activist FDA: Transformation Agent,” Prevision Policy founder and former Pink Sheet editorial head Cole Werble relayed the tale of Acadia Pharmaceuticals, a San Diego-based company with a stage three compound (pimavanserin) targeting Parkinson’s disease-related psychosis.

A month ago, Acadia met with FDA to discuss the proper design of a new phase III trial intended to confirm the results of a previous, 17-month study that met its primary endpoints. A confirmation trial was needed, Acadia presumed, since the first phase III trial of pimavanserin, conducted in 2009 at half the dose of the successful trial, had failed. Acadia had already begun to enroll patients in the confirmation trial – which represented an $18 million commitment – when it met with FDA in April to get the agency’s blessing.

To Acadia’s surprise, FDA responded that the additional confirmation trial wouldn’t be necessary, based on the pivotal phase III trial already on the books, combined with supportive data from other studies on pimavanserin. As a result, Acadia scrapped plans to do another trial, and began preparing its NDA posthaste. But the company wasn’t hasty enough, and investors dialing in to a call about the FDA meeting balked at the company’s projected filing date – near the end of 2014. Why not file immediately, they wanted to know? Acadia executives’ refrain in response, was, “these things take time.” FDA had reversed the waiting game, making Acadia itself responsible for the delay in review and commercialization of a new product.

This is just one example, of course; it isn’t likely that a big pharma looking to introduce another DPP4 into the market for type 2 diabetes, for example, would be told not to worry about additional trials studying cardiovascular or pancreatic side effects. But the fact remains that FDA approved 39 NDAs in 2012 – the most since 1997 – and the agency launched yet another expedited regulatory pathway – breakthrough therapies – at the beginning of 2013. The breakthrough therapies designation is likely to shorten the timeline from discovery to commercial approval – for those drugs receiving the designation – to between three and five years, according to IMS estimates.

Rachel Sherman, associate director of medical policy and director of the Office of Medical Policy, CDER, FDA

The timeline from discovery to approval could be as short as 26 months, said Rachel Sherman, FDA’s associate director of medical policy at the Center for Drug Evaluation and Research (CDER). Sherman said her office had received – to date – 39 requests for breakthrough therapy status, of which 12 have been granted and 14 denied, with 11 pending and two withdrawn. She said the breakthrough therapies program is already “an enormous success.”

Joseph Herring, CEO at Covance, noted that pharmaceutical companies are often difficult to work with, from his perspective as the head of a CRO. “[Investigators] want a perfect trial that can’t be enrolled.” He wondered about the interplay companies have with FDA regarding trial design discussions. In response, Sherman advised more communication. “If what we say doesn’t make sense, ask us. Argue with us. We’re receptive to it.”

How does a company know whether it’s sufficiently engaged with FDA? “If your lead clinical person is on a first name basis with the [respective] lead reviewer at FDA, you’re in good shape,” said Sherman. “If you’re not, you’re not.” Sherman cited the Clinical Trials Transformation Initiative as another program aimed at “identifying and promoting practices that will increase the quality and efficiency of clinical trials.”

“The point of all our programs is better evidence generation…we lack evidence,” said Sherman. “The most expensive drug is the one given to the wrong patient, or given incorrectly.”

On the subject of biosimilar approvals, Sherman said FDA hasn’t received a single application yet, adding that the phrase “follow-on biologics” is dead. The requirements for biosimilars, according to Sherman, are that a biosimilar be “highly similar” to the original product, with “no clinically meaningful differences.” Sherman said that does not mean “interchangeability,” though, suggesting that a biosimilar could not be substituted for a brand biologic at the pharmacy, without specific doctor’s orders.

Comparing the current activist FDA with the activism the agency demonstrated during the HIV epidemic, Werble said that in addition to the breakthrough therapies designation, FDA has also launched the GAIN ACT, and its anti-infective exclusivity provision; has opened up FDA meetings to rare disease outside consultants, who advise companies on efficient FDA regulatory navigation; and has implemented PDUFA 5’s “patient-focused drug development meetings,” which solicit patient opinions around specific diseases.

Speaking on the “agency-wide impact of management attention and staff commitment” mustered during the HIV crisis 20 years ago, Werble said the pendulum has once again swung back toward FDA activism. “That commitment [to HIV] was infectious 20 years ago, and it’s occurring again,” said Werble. He also noted that a solid one-third of all drug applications submitted to FDA now come from small companies, a rejection of the thesis that only big pharma is properly equipped to navigate FDA’s regulatory structure.

The Rutgers Business School Annual Healthcare Symposium, convened on April 30, was presided over by Mahmud Hassan, director of the Blanche and Irwin Lerner Center of the Study of Pharmaceutical Management Issues, at Rutgers. John Castellani, president and CEO of PhRMA, and Seyed Mortazavi, president of IMS Health US operations, also gave presentations.

The Food and Drug Administration appears likely to benefit from sequester-flexibility efforts due to its unanticipated effect on user fee revenues. In addition to FDA contending with the 7.8% reduction in funding for its appropriated funds, as with other federal agencies, the Office of Management and Budget (OMB) has determined that the budget reduction policy applies to user fees paid by manufacturers to support specific FDA approval and oversight functions. FDA thus is collecting all its authorized fees, including recently renewed fees on prescription drugs and the new levy on generic drug companies, but is unable to touch a good chunk of the money.

FDA commissioner Margaret Hamburg explained at the annual meeting of the Food and Drug Law Institute (FDLI) last week that the agency will lose about $209 million this year due to sequestration — $126 million in budget authority and $83 million in user fees. FDA will continue to collect the fees, but the sequestered amount will remain on deposit in the U.S. Treasury and cannot be used to support “critical tasks” such as issuing regulations and guidances, conducting inspections and speeding approvals of new drugs and biologics.

At a recent hearing by the House Appropriations subcommittee that oversees FDA’s budget, Rep. Sam Farr (D-Calif) and other Democrats raised the possibility that Congress will look to provide flexibility in applying the sequestration policy to FDA, especially for fees collected from the private sector.

In response to questions about the impact of the sequester, Hamburg told the panel that without full user fee revenues, “we obviously will fall behind” in meeting performance goals. The agency will be slow putting out guidances, reviewing applications, making new hires to support new programs, improving business processes to make regulatory pathways more efficient and developing new regulatory tools that could “make our system better able to handle more sophisticated products.”

The budget cut could mean fewer meetings between FDA review staff and sponsors of new drugs. FDA’s system for regulating drugs and medical products “works better,” Hamburg explained to the legislators, when reviewers can work closely with sponsors to determine what data is needed and what kinds of studies are important to do to support a new product. And fewer resources “will certainly limit the staff’s ability to engage in those activities,” she said.

Hamburg said at the FDLI meeting that having adequate resources is a “constant concern,” and that she is “enormously troubled that FDA’s responsibilities continue to outstrip available resources.”  And she told the House panel that it was very “troubling” to negotiate commitments with industry to justify fees and then see some of the money going “into a bank” and not available to support FDA programs and activities. If these cuts continue, she stated, “it will have an impact.”

To launch the initiative, PCORI is providing $68 million to fund eight Clinical Data Research Networks (CDRNs) formed by hospitals and health care systems for 18 months. The networks will access electronic patient health records held by members to support observational and interventional studies on large, defined populations. Additional Patient-Powered Research Networks (PPRMs) established by patient and disease groups will collect and analyze patient data on targeted and rare conditions.

The goal of this national research data infrastructure is to improve patient outcomes by accelerating patient-centered and methodological research. The system will examine ways to govern and use large clinical databases to facilitate rapid, efficient conduct of both randomized trials and observational studies.  PCORI will establish a Coordinating Center for the networks, and a Steering Committee will assess policies, best practices and methods needed for an efficient and interoperable research system.

Standards for collecting and analyzing patient health data are particularly important in providing the Food and Drug Administration with “actionable information” that is reliable, pointed out Janet Woodcock, director of the Center for Drug Evaluation and Research. FDA has been developing methodological standards for its Sentinel drug safety data system that obtains drug use information from health system data banks, and the PCORI network would support that program.

John Castellani, president of the Pharmaceutical Research and Manufacturers of America (PhRMA), noted at the PCORI briefing that sponsors are spending billions of dollars on clinical trials, and that “anything done to improve and quality and efficiency of the system will benefit patients.” He expressed caution, though, that “you can’t just take the data and expect it will be useful,” noting that there is a lot of “noise in databases” and that it’s often difficult to identify “true signals” of safety problems. Woodcock explained that linking the use of a specific medicine to any particular health outcome is tricky, and that research on causal inferences requires “a level of rigor.” Studies that can fill gaps in knowledge about interactions of drugs with other drugs and with interventions is particularly important, she noted, as is long-term data on most conditions.

A main benefit of the envisioned research network is to help researchers and clinical trial sponsors identify patients to participate in studies. The data also could help sponsors design clinical trials by providing an understanding of why certain patients don’t respond to treatment and what endpoints may be important for a study,  points out Robert Dubois, chief science officer at the National Pharmaceutical Council (NPC), which tracks PCORI and CER activities.

A coordinated, sustained approach to collecting and assessing outcomes data would be highly beneficial, says NPC analyst Jennifer Graff,  provided it addresses a number of important issues: who has access to research data, ensuring data privacy, considering patient heterogeneity and developing standards for analyzing data. Once a drug is on the market, observes Dubois, broader patient data can help assess its performance in the real world, provided “ the analysis is right.” Graff notes that 18-months to establish these networks is a “very short time frame for data networks to come together and deal with these issues.”

Woodcock further discussed the need for standards and “appropriate analytical rigor” for outcomes research at this week’s DIA-FDA Statistics Forum in Bethesda, Md. Despite considerable enthusiasm for CER, making causal inferences “is a whole other game,” she cautioned.  People need to understand limits on the reliability of health systems information, and that “getting a wrong answer doesn’t help.” She noted that the nation’s enormous investment in electronic health records and CER is generating a massive amount of health data, and urged statisticians and other experts to “help us learn how to use it.”

Many of these challenges will be addressed by PCORI’s newly appointed chief science officer, Bryan Luce, a leading expert in the medical outcomes research world. Luce has been involved in methods and policies related to evidence-based research and will be responsible for leading the development of PCORI’s CER agenda.

At the beginning of the Reboot Camp – held at New York City’s Alexandria Center on April 12 – Intouch Solutions’ CEO Faruk Capan declared the days of Don Draper effectively over. The route to patients’ hearts and minds isn’t Old Fashioned cocktails and intuition; it’s solutions based on patient, provider and payer needs, and making disparate data streams pool around brand objectives.

Katherine Patterson, global marketing communications manager, growth initiatives, GE Healthcare

Katherine Patterson, global marketing communications manager, growth initiatives, at GE Healthcare, gave the keynote address, which focused on clarity of mission in marketing execution, and the importance of marrying science and emotion for consumers. Marketers too obsessed with social media, or the newest digital platform, might impress only themselves. “It’s like peeing down your leg…hot to you, but nobody else,” said Patterson. In Japan, for example, GE Healthcare’s medical device customers “are moving back toward print” as a preferred marketing channel, although growth markets “want digital,” and they want it on their mobile devices, she said.

Citing Eric Topol, currently director of the Scripps Translational Science Institute, Ben Chodor, CEO at Happtique, said we’re not too far away from a time when physicians prescribe more apps than pharmaceutical drugs. Chodor is betting on Topol’s prediction; Happtique, a mobile health application store, will “curate” mobile apps for docs through a private, customized dashboard of Happtique-certified health apps. The company’s patent-pending software would allow physicians to electronically prescribe apps to patients. Chodor says he’s lobbying the SEC to reimburse medical apps, noting that some private plans already do.

Happtique doesn’t make apps itself, but Chodor appeared before the US House of Representatives’ Energy and Commerce Subcommittee on Communications and Technology in March to support FDA’s regulation and definition of mobile medical apps. “It’s relatively simple to take an app through FDA” [for a medical device designation], and it only costs between $10,000 and $20,000, he said, noting that 75 mobile devices/apps have already been approved. Chodor said the Affordable Care Act’s medical device excise tax – “the absolute worst tax ever” – should not be levied on smartphones or apps.

Asaf Evenhaim, co-founder and CEO of Crossix, reminded Reboot Camp attendees about the unfathomable amount of individual consumer or patient data that exists for marketers, while insisting on the importance of privacy and HIPAA regulations. His company collects this data to create “propensity scores,” which serve as the basis for highly specific predictive models. The models can then be used to predict healthcare purchase decisions.

Where does all that data come from? Some of it is volunteered, some is collected invisibly through cookies, Facebook and other online aggregators, and some of it – but not Crossix’s data – is gleaned from trolling social media channels and blogs. Passive data collection, said Intouch Solutions’ senior vice president David Windhausen, is revolutionizing pharma marketing and health itself. Windhausen said he looks at his Nike FuelBand in the evening, and if he hasn’t been active enough, it’s time to exercise.

Windhausen’s talk lovingly described the Sanofi mobile app “GoMeals,” an app for diabetics specifically, but also for anyone who wants on-the-go nutritional facts about nearby restaurants (among other things). An attendee representing Sanofi – which is an Intouch client – let slip that GoMeals, and possibly the iBGStar glucose meter, would start to integrate passive data from wearable tracker gadgets like Fitbit or the FuelBand as early as this year.

Capping off the Reboot meeting was Augustin Fou, founder and chief digital strategist, Marketing Science Consulting Group. Fou emphasized the importance of recognizing how patients’ habits, expectations, and actions – in the context of healthcare – have changed, and how they continue to change. He referenced a Capgemini Consulting report on “digital maturity” that placed pharma at the very bottom of the list.

Despite regulatory hurdles and because of an explosion in mobile technology, data capture, and the influence patient’s have on the delivery of healthcare, pharma marketers could use a reboot. But they’ll need to back-up some of the dusty old tropes of yesteryear, even those that precede Don Draper. As GE Healthcare’s Patterson noted, Aristotelian rhetoric, comprised of ethos, pathos and logos – in equal measure – works as well in a sales detail as it did in symposia. The occasional Old Fashioned might be okay, too.

One man’s goof is another man’s growth, potentially.

A study funded by Becton Dickinson and Company (BD) and published last December in American Health & Drug Benefits found that adverse events associated with injectable medication error in the clinical setting increase US payer costs by anywhere from $2.7 to $5.1 billion a year. On average, that’s $600,000 in extra costs per hospital due to improper administration of injected drugs.

BD Rx – a recently formed subsidiary of BD – will oversee the production and regulatory approval of a new line of pre-filled generic syringes. The first drug in the BD Simplist product line is an antihistamine injection called diphenhydramine hydrochloride, or generic Benadryl. Mark Sebree, president of BD Rx, says the line will span categories including antiemetics, blood modulators, pain management drugs, anesthetics, and other categories. The BD Rx subsidiary has no plans to develop biosimilars or branded vaccines, says Sebree.

Pre-filled syringes in commonly-used dosages can help prevent medication errors since each syringe has its own barcode and label, says Sebree. “Because these products are pre-filled and pre-labeled, and because the vast majority of these drugs are actually administered at the bedside, the label travels all the way to the patient,” meaning physicians or nurses get a second look just before giving an injection. Pre-filled injections also eliminate “the possibility of transcription error,” or incorrect data entry, one of the leading causes of medication error, says Sebree.

“We’re entering a market that, by our assessment, is worth $1.2 billion…our products will target 50% to 70% of that market,” says Sebree, adding that several group purchasing organizations (GPOs) have already signed agreements with BD Rx to purchase the syringes. The BD Simplist line of pre-filled syringes will be priced slightly higher than traditional injections, but at the hospital level, “there doesn’t seem to be any level of surprise about the price we’re requesting for these products,” says Sebree.

BD Rx has filed six other generic pre-filled syringes with FDA, and expects to launch between 20 and 30 products in the next three or four years, says Sebree. The approval of generic Benadryl marks BD’s first foray into pharmaceutical manufacturing. The company’s bread and butter are medical supplies and devices. On an analyst call last week, BD CEO Vincent Forlenza said the company expects the BD Simplist line to generate “incremental revenues of about $100 to $200 million by the end of fiscal year 2017.” BD Rx is targeting only the US for now, but “will certainly evaluate other geographies” going forward, says Sebree.

To read the March cover story in the PharmExec digital edition, click here.

Last Tuesday, the CDC reported that carbapenem-resistant Enterobacteriaceae (CRE) is spreading in inpatient medical institutions across the US, and called for enforcement precautions in these facilities to be implemented. UK Chief Medical Officer Sally Davies echoed such sentiments over the weekend by addressing antibiotic resistance as a worldwide problem needing urgent global action to fill the void in the antibiotic drug development gap. Methicillin-resistant Stapholococcus aureus, or MRSA, is highlighted as one such resistant organism wreaking havoc, causing more deaths annually in the US than HIV/AIDS.

Regulators, politicians and academics are working toward a solution to the antibiotic drug drought. Since it implemented the Generating Antibiotic Incentives Now (GAIN) Act last October, FDA has granted Qualified Infectious Disease Products (QIDP) status to a number of drugs, including most recently Cubist Pharmaceutical’s ceftolozane/tazobactam combination and Furiex Pharmaceutical’s avarofloxacin for their potential to combat particularly resistant pathogens, and also the latter’s ability to stifle a pathogen’s development of resistance. Under the GAIN Act, these new antibiotics gain certain developmental incentives, including priority review and Fast Track status, and, if approved by the FDA, a five-year extension of patent exclusivity on top of the Hatch-Waxman guarantees.

Beyond the GAIN act, there is a call to create an accelerated approval mechanism similar to that of orphan drugs. In 2012, the Infectious Disease Society of America (IDSA) proposed the Limited Population Antibacterial Drug (LPAD) pathway, with smaller, sleeker trial designs as a way of quickening the pace of antibiotic R&D and expediting the approval process. If implemented, LPAD would bring prices up on novel antibiotics, for the same reasons orphan drugs command a high price: to ensure manufacturers develop drugs for small populations in need of treatment, and reduce the cost burden associated with resistance, which exceeds costs of $26 billion in the US alone, according to IDSA. Higher prices for antibiotics would also promote careful use and safer prescribing practices among healthcare providers, to help prevent new drug resistance.

Steve Gilman, EVP of R&D and chief scientific officer of Cubist, explains: “If you’re providing a life-saving benefit that reduces length of hospital stay and cost, then you should have a pricing situation that fairly and equitably provides a return for the value created.” Also, smaller trial designs will allow drug companies to target patients with only the resistant infections as a way of demonstrating efficacy, while mitigating the risk of inducing resistance to the medicines being tested.

Last month, the FDA held a discussion panel in which it was brought up that LPAD has yet to establish meaningful clinical endpoints, and that the potential for these drugs to be used off-label is perhaps what caused this type of resistance in the first place. It was agreed that both considerations warrant further examination of the pathway. The IDSA points out that with effective stewardship programs, off-label use would be carefully scrutinized to ensure resistance is not developed. A recent Lancet Journal article discusses additional clinical trial designs as potential routes to expedited approval and access to antibacterial treatments.

Antibiotic resistance is also a global public health issue. The need for regulatory harmonization across markets is one that coincides with CMO Davies’ point that the effort to refill the antibiotic pipeline requires a global approach. However, if antibiotics are priced at a premium to spur development efforts from big pharma, drug-resistant infectious disease rates in poorer nations (case in point India, with its poor track record of easily accessible antibiotics, and where, coincidentally, MRSA rates are as high as 70% in certain regions) will continue to increase.

Moreover, financial incentives even within the US are shaky and few big pharma companies have expressed a renewed interest in antibiotic R&D. One of the latest examples is Roche’s Genentech partnering with RQx Pharmaceuticals to help fund their research efforts. The crux of the matter, as the Lancet article concludes, is that “we cannot force companies to do this work—rather, we need to persuade them to want to do it.”

Comment: What’s the best means of persuasion? Give your viewpoint.

Dr. Gregory Geba, who was appointed OGD director last July (2012), says “I entirely support” plans to shift all the chemists out of OGD to a new Office of Pharmaceutical Quality (OPQ), as proposed by CDER director Janet Woodcock.  Yet his memo of March 13 announcing his resignation indicates considerable frustration with the situation. Geba came to FDA from Sanofi, he says, to help “pave the way” for extending generics from conventional pills to more complex dosage forms, and to address a broad range of complex quality and regulatory issues. But he notes that the shift of his chemistry group to OPQ will limit OGD resources and “inevitably resets the scope of responsibilities and remit of our office.”

Ever since the OPQ proposal emerged last fall, OGD staffers have voiced concerns that combining generic and new drug review chemists in the same operation would decimate OGD and complicate the generic drug review process. Moreover, the change appears to counter Woodcock’s move last September of elevating OGD to “super office” status, with Geba reporting directly to her.

Similarly, staffers in CDER’s Office of Compliance are leery about OPQ swallowing up much of its Office of Manufacturing and Product Quality. The idea is to combine operations responsible for evaluating chemistry and manufacturing controls data in applications for new drugs and generics with those overseeing compliance with good manufacturing practices, but so far, the change appears disruptive to many CDER officials.

Whatever the merits of Woodcock’s organizational changes, Geba’s sudden departure comes at a difficult time. OGD and manufacturers are immersed in the details of implementing a major new user fee program as well as issuing new guidance and refining programs to smooth the development and approval of safe and high quality generic products. Geba noted in his memo that OGD has approved nearly 200 Abbreviated New Drug Applications (ANDAs) since it began collecting user fees last October, and that it’s beginning to whittle down the massive application backlog.

He also notes that to continue these improvements, OGD plans to hire 100 new staffers and to implement a number of new initiatives – prospects that likely will be undermined by depleted resources under the current budget sequester and a continued impasse in Congress over spending limits. No surprise that someone with a strong resume might not want to stay around to deal with all of this.

In the usual political gamesmanship that accompanies government budget stalemates, the administration cancelled visitor tours of the White House and delayed access to national parks, blaming Congress for failing to deal with the budget impasse. Reductions in airport services threatened flight cancellations. The Centers for Disease Control and Prevention (CDC) predicted difficulties tracking and identifying outbreaks in infectious disease, and the Obama administration warned of reduced funds for childhood vaccines. The National Institutes of Health said its loss of $1.6 billion in funding (on its $31 billion budget) would translate into 2000 fewer research grants, diminishing prospects for new treatments for cancer and other serious diseases.

These and other reductions in government services really go into effect March 27, when employee furloughs without pay begin at many agencies. FDA officials say the agency can avoid reductions in staff, but that the impact will be felt on fewer field inspections and problems meeting application review time frames, scheduling meetings, developing new guidances and rules, and a host of agency functions.

A key issue is whether FDA can gain authorization to spend the new and increased user fees it has been collecting for the last six months. Congress needs to authorize the agency to collect the newly established and increased fees and to rule that sequestration should not apply to all the fees, but has been reluctant to do so. There is some $82 million in fees in question, which FDA desperately wants to tap.

Even more disastrous for the nation than sequestration is the prospect that Congress will let the current continuing budget resolution (CR) expire; if that occurs on March 27 it would end current funding for most government programs. Because Democrats and Republicans really don’t want to shut down the entire federal government, Senate and House leaders are working hard to at least extend the CR through September of this year.  Under the latest Senate budget proposal, the CR legislation also would provide additional funding in many areas for the rest of the 2013 fiscal year. Here, FDA benefits from Sen. Barbara Mikulski (D-MD) now chairing the Senate Appropriations Committee. She has engineered a 2013 budget plan with Republican support that provides $2.5 billion in funds for FDA for this year, including added resources for foreign inspections, food and drug safety and agency operations. With all its $1.8 billion in user fees, the agency would have $4.3 billion in funding, slightly more than for 2012.

The Senate plan also provides an extra $71 million for NIH, but that’s just a token in light of the $1.6 billion hit under sequestration. And no one expects sequestration cuts will be restored.

Key policymakers also are rolling out proposals for a compromise budget plan for 2014, due in April for the next fiscal year beginning Oct. 1, 2013. The latest Republican budget plan calls for transforming Medicare into a voucher program, cutting Medicaid and eliminating the Obama health reform program; at a minimum it cuts millions authorized for implementing insurance exchanges and other reform components. Those health proposals failed to gain public support last November and don’t carry much weight in the Senate. Yet Democrats will have to agree on serious reductions in outlays for entitlements and social programs to enact a workable spending program, and that will require strong presidential and congressional leadership. Every interest group – including research scientists and pharma companies – have been trooping up to Capitol Hill to beg for special treatment for their particularly vital programs, but there’s not much extra money lying around.

For guest blogger Tom Norton’s previous take on pharma and The Sequestration Transparency Act of 2011, click here.

The line between physician marketing and consumer marketing has blurred as the facets of a brand campaign – from disease and drug-mechanism education to efficacy, safety and lifestyle claims – dovetail across the traditional physician-patient separation.

“We know that DTC advertising is often the catalyst for patients initiating conversations with their physicians about their untreated or undertreated conditions,” wrote Janet Woodcock, director of the Center for Drug Evaluation and Research, in an email on the changes. “The decision to restructure the divisions reflects our commitment to continue providing close oversight of DTC advertising.”

Before it got upgraded to a “Super Office” in 2011, OPDP was fondly (or sometimes not so fondly) called DDMAC (dee dee mac), which stood for the Division of Drug Marketing, Advertising and Communications. When DDMAC turned into OPDP, the office was split into two divisions: the Division of Consumer Drug Promotion, and the Division of Professional Drug Promotion. As OPDP, the steady stream of warning and untitled letters continued unabated, mostly chastising pharma marketers for misbranding, off-label, overstating the efficacy or minimizing the risks of a product, or the misuse of a color scheme, in one famous educational piece created for Novartis.

With today’s announcement, ODPD, pending final review, will rename its two primary divisions. They will now be called the Division of Advertising and Promotion Review I, and the Division of Advertising and Promotion Review II. Review of promotional materials will be separated and organized by therapeutic class, not by professional or consumer. “ODPP concluded that a structure that integrates the review of health care professional-directed and consumer directed promotion across the two divisions” would meet the stated goals of increasing efficiency, improving work distribution, and eliminating redundancy, wrote Woodcock.

“Our ODPD reviewers will continue to use a comprehensive surveillance, enforcement, and education program to foster superior communication of labeling and promotional information to both health care professionals and consumers,” she wrote.

Tom Abrams remains head of ODPD. For a list of the new review groups categorized by therapeutic area, click here.