May 14, 2013 — The FDA’s Office of Prescription Drug Promotion (OPDP) will be holding an Enforcement Webinar May 16, from 11:30 a.m. to 12 p.m. (ET), to give stakeholders an opportunity to directly communicate with OPDP staff about clarifications or questions concerning recent enforcement letters issued by OPDP. This particular webinar will cover the six Untitled Letters issued by OPDP from November 2012 through March 2013.
These focused Webinars “support OPDP’s mission to protect the public health by assuring that prescription drug information is truthful, balanced, and accurately communicated,” according to OPDP. Viewers can begin submitting questions 30 minutes prior to the Webinar start time.
Meeting details are listed below:
To join the meeting:
Conference Number(s): 877-231-0558
Participant Code: 9291
April 4, 2013 – A new White Paper, “FDA Communications Oversight in a Digital Era,” issued April 2 by Eye on FDA/Fleishman-Hillard, is based on analysis of a database of FDA/Office of Prescription Drug Promotion (OPDP) enforcement letters, and takes a close look at how, in the absence of FDA guidance on digital communications and social media, the agency enforces alleged violations in these media.
“Lacking any sort of formal guidance from the agency, the only peek into FDA’s point of view is to examine enforcement patterns,” according to Mark Senak, Eye on FDA author and Senior Vice President & Partner, Fleishman-Hillard. For the period of 2008-2012, Senak set out to determine how violations by digital communications properties compared to violations by traditional (non-digital) communications vehicles.
“Given the lack of guidance by the FDA, an examination of regulatory action letters over the period of time during which social media became prominent could provide oversight into (1) whether digital communications led to a change in regulatory actions and (2) potential agency points of view derived from action letters involving social media,” the White Paper states.
Of the 173 letters sent by OPDP during this time period, 26 percent involved the issuance of a Warning Letter and 74 percent were Notices of Violation. Of the 45 Warning Letters issued, only 12 cited digital communications vehicles, the report states, and only a single enforcement letter has been issued regarding a social media platform. In that letter, it was the nature of the social media mechanism that brought about the violation, the author notes.
“As more and more people utilize digital and social media to get healthcare information, getting information about the regulatory parameters in which industry can operate is extremely important,” said John Kamp, Executive Director of the Coalition for Healthcare Communication. “There are still more questions than answers, but this paper sheds some important light onto the patterns of enforcement of digital over non-digital communications.”
For full results and analysis, go to: http://www.eyeonfda.com/eye_on_fda/2013/04/some-digital-and-social-media-guidance-fda-regulation-of-pharma-communications-in-a-digital-era-a-white-paper.html
March 22, 2013 – Although spending on drug promotion has declined in recent years, 2013 could be a pivotal year for the drug industry and its marketing partners. New legislative authority has spured an already energized FDA drug approval staff to focus on novel drugs. The new program, giving prioity for agents in critical areas, builds on recent progress and could signal “the beginning of a new era in drug approvals,” said Coalition for Healthcare Communication Executive Director John Kamp. “Such new drugs are great for patients and give industry new reason to energize flagging marketing programs.”
Speaking March 19 at the Drug Information Association’s Medical and Scientific Communications 2013 Annual Forum held in Chandler, Ariz., Kamp told attendees that in addition to the new drug approvals program recently adopted by the FDA’s Center for Drug Evaluation and Research (CDER), the FDA Safety and Innovation Act (FDASIA) provides incentives for breakthough products and antibiotics. These augment the biosimilar approval pathway created in the Affordable Care Act.
“It is not surprising that drug promotion rates declined in recent years as approvals slowed down,” Kamp said. “But current upward approval trends — including a recent record of 39 approvals in 2112 — combined with the CDER program to speed the approval of breakthrough products, makes it nearly certain that marketing opportunities will increase in 2013. While most of the new products are speciality products, not the blockbusters of the past, they are new products nonetheless and many will grow into substantial markets.”
But the recent numbers published by PLOS tell a different story over the past several years. The study, “Promotion of Prescription Drugs to Consumers and Providers, 2001-2010,” which was released March 4, states that a number of factors appear to have had an impact on drug promotion, which peaked in 2004 at $36.1 billion and sank to $27.7 billion by 2010. Its authors propose that those factors include a slowdown in new drug introductions, changes in the pharmaceutical pipeline, patent expiry for blockbuster drugs, and a greater number of approved biologics.
Spending on direct-to-consumer (DTC) advertising dropped from nearly $6 billion in 2006 to $4.4 billion in 2010, the study states. “During this period, television accounted for a decreasing proportion of all DTCA, declining from 62% in 2001 to 54% by 2010. Print DTCA increased 84% 2001-2006, but then declined 24% by 2010. In 2010, internet promotion accounted for less than 5% of overall consumer promotion,” according to the study summary.
“Manufacturers of branded pharmaceuticals continue to expend considerable sums on promotion to consumers and providers,” the PLOS study concludes. “However, in the context of marketplace changes, firms are decreasing spending but changing little about how expenditures are allocated across types of promotion.”
Kamp asserted that new drug development and approval initiatives will help reverse the decline in approvals that industry has seen in the past several years. For example, with FDASIA codifying accelerated approvals, innovative drugs have a better chance of being approved in a timely manner. Further, “breakthrough therapies” – those that show extraordinary clinical effectiveness – have access to “hyper fast” development, he said. And, the Generating Antibiotic Incentives Now Act (GAIN Act) provides five additional years of patent protection for qualified agents targeting priority infections.
“Add these to priority treatment for rare disease drug applications and for pediatric drugs, and the numbers surely will go up,” Kamp predicted. He also pointed out that during the past two years, FDA new drug approvals have increased from where they stood in 2010. [Editor’s note: The recent study did not tabulate spending data after 2010.]
Kamp described the new approval system – known as “The Program” – as including the following features:
- Longer review cycles, but faster review times;
- Better meetings, including outside consultants that will report on system
- More late-cycle meetings to avoid “surprises” to drug sponsors;
- Fewer, “less exciting” Advisory Committee meetings; and
- Fewer late-cycle “complete response letters” and demands for new studies.
How all of the new approval system changes will stack up against some of the current market challenges remains to be seen, but, Kamp told DIA Forum attendees, “the greater number of approvals for new drugs that we saw in 2012 – with even more new drug approvals likely in 2013 – is most definitely an encouraging trend.”
March 8, 2013 – The Office of
Prescription Drug Promotion (OPDP) today announced that it would be restructuring two of its divisions – the Division of Consumer Drug Promotion and the Division of Professional Drug Promotion – to better oversee direct-to-consumer (DTC) advertising.
According to a memo to Center for Drug Evaluation Research staff from Center Director Janet Woodcock, this restructuring – which would rename the divisions the Division of Advertising and Promotion Review I and the Division of Advertising and Promotion Review II –will “increase efficiency, improve work distribution, and eliminate redundancy.”
Instead of placing all consumer-directed marketing materials in one division, the new structure would divide the consumer-oriented
pieces among both divisions, divided by therapeutic class. “These changes will allow OPDP to review [DTC] and health professional advertising more effectively,” Woodcock stated.
“We know that DTC advertising is often the catalyst for patients initiating conversations with their physicians about their untreated or under-treated conditions. It is also a subject of interest and debate among our stakeholders,” she wrote. “The decision to restructure the divisions reflects our commitment to continue providing close oversight of DTC advertising.”
Woodcock also noted in her memo that OPDP 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.”
Nov. 27, 2012 – An Oct. 31 enforcement letter from the FDA’s Office of Prescription Drug Promotion (OPDP) to Cornerstone Therapeutics Inc. for CUROSURF Intratracheal Suspension sent a strong message to medical public relations professionals because it was one of two enforcement letters issued within a two-week period that cited press materials, not the advertising and marketing collateral that OPDP typically targets.
An Oct. 18 letter regarding an investigational product also cited press releases, as well as embedded videos that were posted on a research entity’s Websites.
“While FDA seldom cites public relations materials in enforcement letters, it did so twice recently,” said Coalition for Healthcare Communication Executive Director John Kamp. “Whether it’s a warning shot or a coincidence, it’s time for PR shops to brush up on the rules.”
Specifically, OPDP alleged in the letter to Cornerstone that a professional pitch letter with an attached press release
for CUROSURF is false or misleading because it omits important risk information associated with the use of the drug and that the pitch letter and the press release are false and misleading because they present unsubstantiated superiority claims.
This enforcement letter drew the first question during an OPDP Enforcement Webinar held Nov. 19. A caller asked: “Since the enforcement letter acknowledges that the company’s press release accompanies the pitch letter, what was the rationale for determining the pitch letter must include risk information?”
Robin Tyler, OPDP regulatory counsel, replied that “the healthcare professional pitch letter and press release were intended to be distributed together, but each of these promotional materials is a stand-alone piece, therefore they both require risk information.”
This position is not one that has been enforced explicitly in the past, according to several industry experts. Wayne Pines of APCO Worldwide told Medical Marketing & Media that “OPDP has viewed press materials as promotional labeling for many decades.” He noted, however, that “the pattern of enforcement letters indicates that press materials have not been a high priority for enforcement” and may be a “wake up call” to companies that do not use the same standard for press materials as they do for other forms of promotion.
During the Webinar, OPDP enforcement officials discussed a broad range of alleged violations and reiterated past comments that they are looking for voluntary compliance from industry. OPDP also listed the common alleged violations cited in two Warning Letters and 16 Untitled Letters issued from May 2012 through October 2012, which included:
- Omission/minimization of risk
- Unsubstantiated claims (including unsubstantiated superiority claims)
- Overstatement of efficacy
- Omission of material facts
- Broadening of indication
- Inadequate communication of indication
- Promotion of unapproved uses
- Inappropriate reminder labeling
- Misleading claims/presentation
- Failure to fulfill “adequate provision” requirement
- Failure to submit under Form FDA-2253
- Inadequate presentation of established name
In response to various questions from viewers regarding specific enforcement letters, OPDP officials stated that industry should consider the prominence of risk information as it relates to benefit information, avoid expanding indications with claims, ensure that patients used in testimonials represent “typical” patients, and use only primary endpoints as the basis for promotional claims. Several
OPDP officials also advised companies to actively discuss their promotional approach with OPDP review divisions.
“One of the ways we really promote is for industry to send in pieces for advisory comment, especially if they are doing something slightly different or have a new campaign,” according to Ernest Voyard, OPDP regulatory counsel. “We are here to help with review and we encourage industry to take advantage of it,” he said.
Nov. 7, 2012 – Analysis of the FDA’s Office of Prescription Drug
Promotion’s regulatory action letters since 2005 shows that although risk minimization and overstatement of efficacy are the most frequently cited alleged violations across the full array of media (64 percent combined), that number goes up considerably – to 80 percent combined – when breaking out videos and DVDs (not including DTC broadcast) from other media, according to a
Nov. 6 blog entry on Eye on FDA.
“One can see that as a communications vehicle, videos have their own issues when it comes to staying within regulatory communications confines,” Mark Senak writes. He notes in the blog that patient or physician testimonials and the placement of risk information are particular challenges that industry faces when making videos.
To view the full Eye on FDA blog entry, go to: http://www.eyeonfda.com/eye_on_fda/2012/11/viewing-videos-regulatory-profile.html
Oct. 15, 2012 – The FDA’s Office of Prescription Drug Promotion (OPDP) recently announced that it will hold its next Enforcement Webinar on Oct. 29, from 11 a.m. to 11:30 a.m. EST.
The OPDP enforcement Webinar, which covers Warning
Letters and Untitled Letters issued from May 2012 through mid-October 2012, will give stakeholders an opportunity hear from and directly communicate questions to OPDP staff. Viewers can begin submitting questions 30 minutes prior to the Webinar start time.
“These focused webinars support OPDP’s mission to protect the public health by assuring that prescription drug information is truthful, balanced, and accurately communicated,” OPDP stated. To review the Coalition for Healthcare Communication’s coverage of
the last OPDP enforcement Webinar, see http://www.cohealthcom.org/2012/05/07/common-marketing-violations-still-occurring-opdp-says-in-2012-q1-enforcement-webinar/
Details regarding the upcoming Oct. 29 meeting are listed below.
To join the meeting:
Conference Number(s): 301-796-2700
Participant Code: 262699
If you have never attended a Connect Pro meeting before:
Test your connection: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm
Get a quick overview: http://www.adobe.com/go/connectpro_overview
July 16, 2012 – The FDA’s Office of Prescription Drug Promotion (OPDP) is on pace to deliver the same number of enforcement letters it sent out in 2011, having issued 15 Warning or Untitled Letters to date in 2012. OPDP had issued 17 such letters by this point in 2011.
The seven enforcement letters sent out by OPDP since May 1 were issued for alleged violations relating to a television ad, a branded story, a journal ad, a Web page, a patient brochure and two video segments. OPDP discovered problems with these promotional materials as a result of routine surveillance and monitoring (1), review of materials under Form FDA-2253 (5) and via a complaint received under the agency’s “Bad Ad” program (1).
In a May 25 Warning Letter, OPDP charges that a Pfizer Inc. TV ad for EPIPEN and EPIPEN JR. is false and misleading because it overstates the efficacy of the products. Specifically, the agency took issue with the “overwhelming impression” created by the ad that the EpiPen alone could provide assurance that a child with life-threatening allergic reactions does not need to worry or take precautionary measures to avoid exposure to allergens, according to OPDP. “This violation is particularly alarming from a public health perspective because the misleading presentation of the use of EpiPen may result in serious consequences, including death,” the Warning Letter states.
An Untitled Letter sent to Vertex Pharmaceuticals Inc. on May 25 found fault with a branded story that the company submitted to OPDP for INCIVEK Film Coated Tablets. The letter states that although claims made in the branded story may be an accurate reflection of the story subject’s experience with hepatitis C and treatment with Incivek, it misleadingly implies that most or all similar patients will achieve the same results. “One patient’s treatment response does not constitute substantial evidence,” OPDP states in the letter, which also cited Vertex for omission of material fact and minimization of risk information.
OPDP objected to a journal ad for Watson Pharmaceuticals Inc.’s NULECIT due to unsubstantiated claims, according to a June 7 Untitled Letter. OPDP alleges that the journal ad claims there is a reduced need for erythropoiesis-stimulating agents (ESAs) with Nulecit use and that there are significant cost savings when the drug is added to ESA therapy.
As part of its routine monitoring and surveillance, OPDP reviewed an “efficacy” Web page for KEPIVANCE and found it to be false or misleading because “it omits and minimizes important risk information and makes misleading efficacy claims.” The June 7 Untitled Letter, sent to Quintiles Inc. as the U.S. agent for Swedish Orphan Biovitrum AB, states that although the Web page links to the Prescribing Information and the Kepivance Safety and Tolerability sections of the Web site (which includes the drug’s risk information), “these links are not sufficient to mitigate the misleading impression created by the omission.” OPDP also alleges that the Kepivance Web page included misleading efficacy claims and that the promotional Web pages were not submitted to OPDP using Form FDA-2253.
A June 19 Untitled Letter to Pfizer cited a patient brochure for ZMAX, which it alleged is false or misleading because it:
- Omits and minimizes important risk information
- Makes unsubstantiated superiority claims
- Omits material facts
- Broadens the indication for the product
- Makes misleading efficacy claims
- Makes unsubstantiated claims.
For example, OPDP states that the Zmax brochure “minimizes the risks associated with Zmax by failing to disclose that severe and fatal allergic and skin reactions have been observed with azithromycin.” Even though the brochure states that patients should seek emergency help right away if they develop a series of severe side effects, such as trouble swallowing, hives, swelling of the face or tongue or trouble breathing, “failure to disclose the severity of the potentially fatal allergic reactions, including recurrence of the allergic symptoms even when the drug was discontinued … misleadingly minimizes the risks associated with Zmax,” OPDP states in the letter.
Finally, two Untitled Letters – both sent on June 21 – address testimonials in promotional video segments. An Untitled Letter sent to Acorda Therapeutics Inc. states that a video for AMPYRA Extended Release Tablets is false or misleading because it overstates the efficacy of the drug product and minimizes important risk information. In the video, a patient discusses her experience with and treatment for multiple sclerosis and makes statements that may reflect her personal experience, but are not supported by substantial evidence, according to OPDP.
The letter to Acorda also states that statements made in the testimonial minimize risks associated with Ampyra. “Specifically, they imply that patients who experience adverse events, such as paresthesia and insomnia, will be ‘able to get used to it’ and such adverse events will disappear within a month,” the letter states, and “the overall effect of the risk presentation undermines the communication” of important risk information.
In its Untitled Letter to Valeant Pharmaceuticals North America, OPDP alleges that a patient assessment video and a Web page for XENAZINE Tablets for Oral Use are false and misleading because they overstate efficacy, omit material facts and omit and minimize the serious risks of the drug.
The video, in which a case study of one patient is presented showing “before and after” shots, overstates the product’s efficacy, the letter states. These presentations “are misleading because they suggest that treatment with Xenazine will lead
to significant improvements in balance, walking and postural stability in patients with Huntington’s disease, when such benefits have not been demonstrated by substantial evidence,” the letter states.
OPDP also takes issue with the nearly four-minute video presenting many claims regarding the efficacy of Xenazine while minimizing its risks and “failing to convey any risks associated with Xenazine during this audio-visual presentation” (emphasis original). The letter also states that the video seemingly ignores the boxed warning, contraindications, warnings and precautions associated with the drug. Further, the Web page where the patient assessment video is located “completely omits the risk of clinical worsening and adverse effects associated with Xenazine and the increased risk of somnolence and sedation with concomitant use of alcohol or other sedating drugs.”
Several of the letters issued during this period echo problems cited by OPDP in the first quarter of 2012. In an enforcement update held at the end of April, OPDP Regulatory Counsel Ernest Voyard clarified that patient case studies used for promotional purposes should reflect the general use of the product as listed in the PI. “Companies shouldn’t pick extreme cases that show a clear benefit and hide the risk. It should be an accurate reflection of what patients should expect,” he said. “That being said, it doesn’t have to be a middle-of-the-road patient either, but it should reflect what’s expected.”
Case studies focusing on outlier patients are “probably dangerous,” Voyard noted. “The exceptional patient is an outlier, and any outlier can be problematic,” he said. “A [case study] patient has to experience some of the benefits and some of the risks – not necessarily every benefit and every risk
– but the [case study patient] should address the general experience.”
June 4, 2012 – In recent comments to the FDA regarding a draft guidance that would call for prior review of six categories of direct-to-consumer (DTC) television ads, the Pharmaceutical Research and Manufacturers of America (PhRMA) stated that it is “concerned” that the FDA’s proposal infringes on the drug industry’s First Amendment rights.
Coalition for Healthcare Communication Executive John Kamp predicted back in April that a First Amendment challenge to the draft guidance – which describes the full array of DTC TV ads the FDA intends to make subject to a pre-dissemination ad review provision mandated by the Food and Drug Administration Amendments Act of 2007
– was possible. See http://www.cohealthcom.org/2012/04/09/fda-draft-guidance-on-dtc-tv-ads-raises-important-questions/
“I suspect the draft guidance will spark some interesting comments,” Kamp said in an April 9 column on the Coalition Web site. “Indeed, the guidance may be challenged under a provision in the FDA statute limiting pre-reviews, or perhaps even more dramatically as a violation of the ‘prior restraint’ limit on speech under the First Amendment.”
According to PhRMA, the draft guidance is, “in important respects, overbroad, unduly burdensome and lacking in narrow, objective, and definitive standards” and should be withdrawn, with any new proposal implemented “by means of notice and comment rulemaking in a tailored, risk-based approach that conforms with the Supreme Court’s directive [in Central Hudson] that ‘the First Amendment mandates that speech restrictions be narrowly drawn.’”
To support its position that pharmaceutical marketing is a form of speech protected by the First Amendment, PhRMA cites the June 2011 U.S. Supreme Court decision in Sorrell v. IMS Health and states that “DTC promotion – like other forms of advertising and promotion – is commercial speech that is protected by the First Amendment.” Later in the comment, PhRMA states that it is “concerned that FDA’s proposed pre-dissemination review of DTC television advertisements raises significant First Amendment concerns.”
PhRMA and industry commenters on the draft guidance also take issue with the FDA’s proposal that companies submit final recorded versions of TV ads before they are disseminated. “The requirement to submit a final recorded version of a TV advertisement will place a substantial financial burden on submitting companies,” because any FDA comments could force a company to “rework material that has already been fully produced at a significant cost,” PhRMA’s comment states.
This sentiment is echoed in other comments which assert that annotated storyboards of proposed TV ads should suffice for pre-dissemination review.
“The costs of submitting final broadcast ads and then re-shooting them because the FDA takes issue with a few aspects of the ads would most certainly be prohibitive,” Kamp said. “If this provision remains, it would be a huge blow both to industry and to the consumers who seek information about promising treatments.”
The comment period on the draft guidance closed May 14. “FDA’s next steps should be very interesting,” Kamp noted.
May 7, 2012 – Many of the alleged violations cited by the Office of Prescription Drug Promotion (OPDP) in five Untitled Letters and one Warning Letter during the first quarter of 2012 are the same violations the agency has cited in the past. Th
ese violations include:
- Omitting or minimizing risk information
- Making unsubstantiated claims, including superiority claims
- Overstating efficacy
- Omitting material facts
- Promoting unapproved uses
- Broadening indications
Speaking at an April 30 OPDP Webinar on Q1 enforcement actions, OPDP Regulatory Counsel Bryant Godfrey said “quality is improving, but there is still room for improvement across the board. Some companies appear to be getting the message while others don’t.”
The sole Warning Letter issued during this time period was sent to Teva Pharmaceuticals USA for its drug COPAXONE. In the March 14 Warning Letter, OPDP states that exhibit panels and Web pages promoting the drug “are false or misleading because they overstate the efficacy, present unsubstantiated claims, broaden the indication of Copaxone, omit and minimize important risk information associated with the drug, present unsubstantiated superiority claims, and omit material facts.”
Further, the letter states that these alleged violations “are concerning from a public health perspective because they suggest that Copaxone is safer or more effective than has been demonstrated by substantial evidence or substantial clinical experience.”
The FDA took issue with promotional claims related to the duration of treatment experience and years of drug safety for Copaxone, which are not supported on the drug’s package insert (PI). The PI did not support the cited claims, according to OPDP Regulatory Counsel Julie Chronis. “The studies that were cited in the piece did not constitute substantial evidence. These studies were extension, open-label studies,” she said.
OPDP Regulatory Counsel Ernest Voyard further explained that these materials presented information out of context. “This is one of those situations where context kind of matters,” he said. The promotional claims suggested 20 years of use by a single patient not simply that the drug had been on the market for 20 years, he indicated. Chronis added that even when companies cite from the PI, they still have to provide appropriate context.
When asked whether industry should submit diagrams and layout of exhibit booth panels via Form FDA 2253, Godfrey responded, “Yes. The more you can help us out the better.”
One attendee asked why a chart cited in a March 13 Untitled Letter to Biogen Idec regarding AVONEX was problematic, considering that the information used to compare Avonex with other drugs in its class was true. “Even though the information portrayed in the chart was true, it was not complete, because risk information for Avonex and the other drugs was omitted,” Chronis said.
Another member of the audience asked for guidance on when a company could properly discuss a specific use beyond the general indication, a problem cited in a March 30 Untitled Letter to Ferring Pharmaceuticals Inc. for FIRMAGON. “When a drug has a general indication, it can be problematic to discuss those specific uses that have not specifically been approved, for a number of factors,” Voyard said. Companies need to have specifically studied and have substantial evidence to back up those uses, he noted.
Several questions were posed to the
OPDP panel regarding the use of case studies in promotional materials, in light of a Jan. 9 Untitled Letter to Novartis Oncology for GLEEVEC. In the letter, the agency took issue with the use of a promotional case study because although it may have been an accurate representation of one patient’s treatment experience, it found no evidence to suggest that all patients would have a similar experience. “FDA is not aware of substantial evidence or substantial clinical experience to support this suggestion,” the OPDP letter states.
Voyard clarified that patient case studies used for promotional purposes should reflect the general use of the product as listed in the PI. “Companies shouldn’t pick extreme cases that show a clear benefit and hide the risk. It should be an accurate reflection of what patients should expect,” he said. “That being said, it doesn’t have to be a middle-of-the-road patient either, but it should reflect what’s expected.”
Another attendee asked why it was not advisable to discuss a patient that did exceptionally well in a case study. Voyard replied that “the exceptional patient is an outlier, and any outlier can be problematic. A [case study] patient has to experience some of the benefits and some of the risks – not necessarily every benefit and every risk – but the [case study patient] should address the general experience,” he noted. “Outliers are probably dangerous.”
When asked whether companies should stop using case studies, Chronis replied, “We don’t discourage it. We just want to see it done in an appropriate manner.”
Reiterating a sentiment conveyed in the 2011 Q4 OPDP Enforcement Webinar, Godfrey said that “voluntary compliance is key.”