April 18, 2012 – Overview FDA Regulation of Direct-to-Consumer Prescription Drug Advertising

The Food and Drug Administration Amendments Act of 2007 (FDAAA) amended the Food, Drug and Cosmetic Act to require that the major statement in direct-to-consumer (DTC) advertisements relating to the side effects and contraindications of prescription drugs be presented in a “clear, conspicuous, and neutral manner.” The FDAAA also directed the FDA to publish regulations establishing the standards for determining whether a major statement meets the “clear, conspicuous, and neutral manner” standard.

The FDA’s primary goal to be achieved through the regulations is to ensure that information about side effects in prescription drug advertisements is clear and understandable to consumers. The FDA also stated in its notice of proposed rulemaking that prescription drug advertisers will have leniency in their advertisements provided that the overall presentation is accurate and not misleading. The uncertainty for industry will be relying on such apparitional statements of reason in the face of labrynthian legislation that will be highly subjective, requiring interpretation and application to each specific DTC advertisement. With the comment period now closed, the question that arises is what the proposed rules mean to the prescription drug industry.

FDA’s Proposed Rule on DTC Advertising

In the Federal Register of March 29, 2010 (75 Federal Register 15376), FDA published a proposed rule entitled: ‘‘ Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner ’’ to amend its regulations concerning DTC advertisements of prescription drugs. The proposed rule was substantially similar to the FDA’s May 2009 draft guidance on the issue, entitled “Presenting Risk Information in Prescription Drug and Medical Device Promotion.” The proposed rule provided a four-pronged analysis for determining whether risk information is presented in a “clear, conspicuous, and neutral manner,” including:

• The information is presented in language that is readily understandable by consumers;
• Audio information is understandable in terms of volume, articulation, and pacing;
• Textual information is appropriately placed and presented against a contrasting background for sufficient duration, and in a size and font style that allows for ease of reading; and
• The advertisement does not include distracting representations that detract from the communication of the major statement concerning side effects and contraindications of prescription drugs.

The initial comment period for the proposed rule closed on June 28, 2010, and a meager 26 comments were filed. The FDA noted, however, that interested parties would have another opportunity to comment on the proposed rule after the FDA completed its analysis of a study concerning the impact of distraction on consumer understanding of risk and benefit information in DTC prescription drug advertisements.

On January 27, 2012, the FDA announced that it had reopened the comment period based on its analysis of the consumer understanding study involving risk and benefit information in DTC prescription drug advertisements. The reopened comment period was initially until February 27, 2012; however, the FDA again extended the comment period until April 9, 2012. Despite the importance of this study to a multi-billion dollar industry, few comments were submitted.

Summary of FDA’s Distraction Study on Consumer Understanding

In the Federal Register of August 22, 2007 (72 Federal Register 47051), the FDA discussed this study, entitled “ Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements ” (the “Distraction Study”). The FDA’s analysis of the Distraction Study was made publicly available in January 2012.

The Distraction Study examined a number of factors that could potentially influence viewers’ understanding of the risk information in the audio portion of the advertisement:

• the presence or absence of superimposed text;
• the emotional, or affective, tone of visual images; and
• the consistency of the visual images with the risk information presented.

According to the FDA’s summary of the study, “[t]he results of the Distraction Study indicate that presenting risk information at the same time in text and in audio improves consumers’ understanding of the risk information.” The FDA further summarized that “[t]he results of the Distraction Study did not find support for the idea that consumers’ understanding of the risk information is influenced by the emotional (affective) tone of visual images or the consistency of the visual images with the risk information on the screen during the major statement.”

What Will Be the Practical Effect of FDA’s Proposed Regulations

The primary goal to be achieved through the proposed regulations is to ensure that information about side effects in prescription drug advertisements is clear and understandable to consumers. The difficultly, however, will be speculating as to how FDA will apply the highly subjective proposed rules, which will require interpretation and application to each specific DTC advertisement.

Take for instance a hypothetical DTC advertisement for hypertension, and measure it against the FDA’s proposed four-pronged standard for determining if a DTC advertisement is clear, conspicuous, and neutral. Under the first standard, the DTC advertisement must be understandable in its language. In our example, hypertension must be referred to as high blood pressure. Under the second standard, audio distractions cannot mask the risk message. In our example, the risk information in a voice-over cannot be delivered at the pace of a livestock auctioneer and it cannot be whispered. Under the third standard, if the DTC advertisement presents written text, such text must be easily processed by viewers. Under the fourth standard, the DTC advertisement cannot contain distracting representations that detract from the communication of the major statement of side effects or risks.

It is this last prong of the standard – the prohibition of distracting representations during the major statement – that will likely cause the most uncertainty. The exact language of the proposed regulation provides that a major statement is clear, conspicuous, and neutral if “[t]he advertisement does not include distracting representations (including statements, text, images or sounds or any combination thereof) that detract from the communication of the major statement.” Defining what is distracting may prove impossible, or at least comparable for Justice Stewart’s attempt to define obscenity – “I know it when I see it.” Further, the advertising must be neutral, and it is unclear how “positive” imagery before and after the major statement would be perceived by the FDA. Does a smiling person belie the realities of chemotherapy? Is a beautiful waterfall distracting? How about a tender embrace of a grandchild by a grandfather? The point is that uncertainty is of little benefit to both the regulator and the regulated.

As the above hypothetical shows, the challenges to developing DTC advertisement will likely be substantial, and the risks of non-compliance will lead many industry participants to engage cognitive and psychological consultants to measure consumers’ perception and understanding of DTC advertisements. Vagueness in DTC advertisement could result in a shift away from broadcast advertisements based on pharmaceutical companies’ fear of being sanctioned by the FDA, as has been the case with pharmaceutical marketing on social media websites.

What Troutman Sanders Offers

Troutman Sanders LLP’s Life Sciences Practice Team serves a broad range of clients within the life sciences and associated technology industries from product conception to development and onward through clinical testing and regulatory approval to sales and marketing and post-marketing claims of product liability. If you have any questions about regulations impacting the marketing of prescription drugs and medical devices or developing compliance strategies, please contact Diane Romza-Kutz or another attorney from the Troutman Sanders Life Sciences Team.

The December 30, 2011 draft guidance recommends that “a firm that chooses to respond to an unsolicited request for off-label information provide the final response containing the requested off-label information about its product only to the specific individual who requested the information as a private, one-on-one communication.”  Id. at 82305.  The response should be made by medical or scientific personnel, not by someone in sales or marketing.  Id.  The information provided to the individual should be accurate, balanced, non-promotional and tailored to the specific question asked.  Id.  Such non-public responses to unsolicited requests for unapproved uses of a drug or device should provide data relating to the off-label use, such as medical literature, with full disclosure of any conflicts of interest for all authors associated with the literature.  The responses also should include a copy of the FDA-approved labeling, “prominent” statements that the use inquired about is not FDA-approved, the FDA-approved uses of the product and the relevant safety information, and a list of references for the information included.  Id.  The draft guidance also recommends that the company responding to such an inquiry maintain records regarding the request and its response.  Id. 

When a company provides a public response to unsolicited requests for off-label information about its product, the response “should convey that the question pertains to an unapproved or uncleared use of the product and be limited to providing the firm’s contact information for the medical or scientific personnel or department so that the individuals can follow up independently with the firm… through a non-public, one-on-one communication.  Id. 

 It further provides that “if a firm responds to unsolicited requests for off-label information in the manner described in this draft guidance, FDA does not intend to use such responses as evidence of the firm’s intent that is product be used for an unapproved or uncleared use.”  Id.  The public responses should not be “promotional in nature or tone and should include a mechanism for providing readily accessible FDA-required labeling” for the product.  Id. at 82306.

 The FDA estimates that it will take a company approximately 4 hours to respond to each unsolicited request as recommended in the draft guidance and an additional 15 minutes of recordkeeping for each request.  Id.  This is a substantial burden (id. (estimating 170,000 hours per year), and pharmaceutical and medical device companies will have to dedicate appropriate staff and resources to field and respond to these electronic media inquiries.  Companies also should evaluate their websites and their presence on public electronic forums to determine which are sufficiently helpful to their business strategy and/or customer relations goals to justify the added time, expense and resources necessary to comply with the draft guidance.

The FDA has called for comments on the draft guidance by March 29, 2012.

The plaintiff claimed that the device, which is a component in a system used to deliver medication, failed to operate in accordance with the terms of its premarket approval.  Thus, she argued, her claim was a “parallel” claim not preempted by the MDA.  A 2-1 majority (Judges Duncan and Diaz) disagreed, holding that that “[i]n light of [the plaintiff's] concesson that the device was designed, manufactured, and distributed in compliance with the terms of its premarket approval, given by the [FDA] as required under the MDA,” the claim was preempted.  See Slip Op. at 2.  The court further noted:

The exclusive provisions of the FDA regulatory process recognize only one mechanism for the creation of an enforceable requirement governing the ongoing performance of a medical device, and that is through the establishment of a formal performance standard.  [Plaintiff] concedes that no such performance standard was created here.  This concession makes clear that her common law claims seek to impose requirements above and beyond those of the FDA, thus bringing them within the category expressly preempted by the MDA.  To hold otherwise would be to undermine the balance Congress struck when it enacted the MDA, in which it determined that the benefit to the many of bringing potentially lifesaving, but risky, medical devices to the public following the rigorous process of FDA approval outweighed the cost to the few of preempting common law claims based on different standards.

Id. at 2-3.   Crucial to the case was the Court’s finding that a performance standard associated with the pump was not a formal performance standard approved by the FDA.  Thus, this decision further clarifies the Supreme Court’s 2008 decision in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), and affirms that the malfunction of a medical device that has passed FDA pre-market approval does not necessarily violate the MDA.

Jan. 4, 2012 — On January 4, 2011, President Barack Obama signed the FDA Food Safety Modernization Act (FSMA) into law. The FSMA purports to address perceived problems with the American food safety regime by empowering the United States Food and Drug Administration (FDA) with new regulatory and enforcement authority. The law creates expansive power for the FDA to regulate both domestic food producers and companies importing food products into the United States. Today, January 4, 2012, marks the one year anniversary of the FSMA and many significant steps have been taken to implement the legislation.

This Advisory will highlight a few of the most important regulatory actions taken pursuant to the  FSMA to date and the major implications for business involved in food production and supply.

Reinspection Fee Provisions Now in Effect

Section 107 of the FSMA provides the FDA with the authority to collect fees from the responsible party for each domestic facility and the United States agent for each foreign facility subject to a reinspection. As of October 1, 2011, the FDA began implementation of these fee provisions. Fees will now be assessed if the FDA conducts a reinspection to evaluate corrective actions following a previous FDA inspection of the same facility that was found to be non-compliant with a food safety requirement.

For fiscal year 2012, the hourly rate for a reinspection is $224 if no foreign travel is required and $325 if foreign travel is required. The total fee assessed will depend on the number of hours the FDA spends directly working on the reinspection-related activities or food recall activities associated with a recall order.

The FDA recommends that all firms assess their compliance with all statutory and regulatory requirements in light of this new fee schedule.

Interim Final Rule on the Criteria for Administrative Detention

On May 5, 2011, the FDA issued an interim final rule that significantly strengthens the FDA’s ability to administratively detain food intended for human or animal consumption.  Previously, the FDA was only able to detain food products when the agency had “credible evidence” that a food product was contaminated or mislabeled. Under the new interim final rule, the FDA will be able to detain food products if there is “reason to believe” an article of food is adulterated or misbranded.  Decisions regarding whether the FDA has “reason to believe” a food product is adulterated or misbranded will be made on a case by case basis. Food products may be detained for up to 30 days while the agency determines whether or not to formally seize the goods or pursue a federal injunction to prohibit distribution.

The requirements of this interim final rule went into effect on July 3, 2011. The FDA also published a document entitled Guidance for Industry: What You Need to Know About Administrative Detention of Foods in October of 2011 in order to assist parties in complying with the new requirements.

Interim Final Rule on Prior Notice of Imported Food

On May 5, 2011, the FDA also issued an interim final rule requiring an additional element of information in a prior notice of imported food. This change requires a party submitting prior notice of imported food, including food for animals, to disclose to the FDA if any country has refused entry to the same product.

This new information on imports will allegedly help the FDA target potential risks and will increase the agency’s ability to detain and remove products that may pose a threat to humans or animals.  The interim final rule is effective as of July 3, 2011.

The Authority to Suspend the Registration of Food Facilities

On July 3, 2011, the FDA’s authority to suspend the registration of food facilities became effective. The FDA is now authorized to suspend the registration of a facility if there exists a “reasonable probability that food manufactured, processed, packaged, received or held by the facility could cause serious health consequences or death to humans or animals.” If the registration of a facility is suspended, the facility will no longer be able to introduce food into interstate or intrastate commerce.

If a food facility fails to produce safe products, the facility is now expected to file a food report with the FDA, voluntarily recall the affected product, and take remedial action to keep the products from reaching consumers.

Draft Guidance for the Dietary Supplement Industry

On July 3, 2011, the FDA issued draft guidance to assist the dietary supplement industry in deciding when a premarket safety notification for a dietary supplement containing a new dietary ingredient (NDI) is necessary. The guidance addresses what qualifies as a NDI, when a NDI notification is necessary, the procedures for submitting a NDI notification and what should be included in a NDI notification. The FDA encourages manufacturers and distributors to consult this guidance and to conduct a safety review of any dietary supplement that contains a NDI.  Public comment on the draft guidance was accepted until October 3, 2011.

The FSMA is a comprehensive overhaul of the American food safety regime. This advisory merely seeks to highlight some of the many changes to the regulatory structure that have gone into effect over the course of the past year. For further information about the issues addressed in this advisory or other concerns related to the FSMA, please do not hesitate to contact Diane Romza-Kutz or any member of the Troutman Sanders Life Sciences Team.

The Court stated that in many product liability cases, the place of the injury may carry less weight in a venue proceeding, but noted that a number of factors in this case required transfer of the case to the Western District of Virginia.  Most importantly, the accident occurred in Virginia and a number of necessary non-party witnesses, including the hospital employee who allegedly installed the car seat, the police who responded to the scene and bystander witnesses were located in Virginia.  The convenience to these witnesses in having the case litigated in Virginia as well as the fact that the Court did not have jurisdiction over a number of them militated in favor of transfer.  Additionally, the court seemed to agree with the defendant that “under choice of law rules, Virginia law would apply because Pennsylvania has no interest in the litigation.”

Not surprisingly, less than two months after the decision transferring the case, the plaintiff filed and was granted a motion for voluntary dismissal.  A companion suit the plaintiff filed against the car seat manufacturer, the seat insert manufacturer, the hospital employee who allegedly install the car seat and the driver of the vehicle is still pending the Circuit Court for the City of Roanoke, Virginia.

According to the news articles, Taishan did not respond to the third-party claims because it contends that the Virginia courts do not have personal jurisdiction over it. If that is the case, Taishan took a big risk by deciding not to appear instead of filing a motion to dismiss for lack of personal jurisdiction.

The default judgments are more good news for product supplier Venture Supply, which, as I reported in my blog post dated November 2, 2011, recently prevailed on a demurrer in the Suffolk Circuit Court.

In November, U.S. District Judge Richard Leon issued a preliminary injunction blocking implementation of FDA’s new graphic warnings requirements, which would have required, beginning September 22, 2012, all cigarette packages to display one of nine new textual warnings showing the dangers of smoking, graphic images on the top fifty percent of both the front and rear panels. The new warnings requirement also would require display of a smoking cessation assistance telephone number. The court’s injunction stays implementation of the requirements until 15 months after a final ruling from the court resolving the lawsuit. Opponents were vocal in their dislike for this opinion, citing studies that allegedly show positive effects of graphic warnings used in other jurisdictions.  There were calls for the Justice Department to appeal the ruling.
This action was taken by the Court because it found that the plaintiff tobacco manufacturers had demonstrated a substantial likelihood that they would prevail on the merits of their position at trial.  The manufacturers claim that the new requirements unconstitutionally compel speech, and that their companies will suffer irreparable harm in the absence of injunctive relief.
The reasoning for the decision includes that the graphic image requirements are not purely factual and uncontroversial, making them subject to a stricter analysis applicable to government regulations which compel commercial speech. The Court noted that some of the pictures appeared digitally enhanced to “evoke emotion” and thus the Judge concluded that these were not “purely factual.”
To withstand this stricter analysis, the graphic warnings must be narrowly tailored to achieve a compelling government interest. Noting that FDA’s purpose in promulgating the warning requirements is unclear, the Court said that, regardless of the purpose, the requirements are not narrowly tailored to achieve any government purpose, as demonstrated by the expansive size and display requirements for the new warnings and the existence of alternative means of disseminating the same type of information.
The Court also found that, without the injunction, the plaintiffs would suffer irreparable injury, in a couple of ways, namely (i) in an inability to recover from FDA costs incurred in preparing to comply with the new requirements and (ii) because of the harm flowing from a First Amendment violation.
Although FDA argued that injunctive relief would harm the public, the Court disagreed, finding that Congress’s lack of urgency in passing the graphic warning statute and FDA’s use of the full two-year period to promulgate the final requirements undercut the public harm argument.

Although the defense verdict itself is noteworthy and one that will certainly catch the eye of the plaintiff and defense bars alike, the case is also notable due to several interesting rulings made during the nine-month course of the proceedings.  

Future Earning Capacity of a Minor

In perhaps the most noteworthy pretrial ruling, Judge James Jones allowed the plaintiff’s experts to provide estimates of the child’s future earnings capacity, even though at the time of the accident she was only five years old.  See Musick v. Dorel Juvenile Group, Inc.,  No. 1:11cv05, 2011 U.S. Dist. LEXIS 118354 (W.D. Va. Oct. 13, 2011).  In Virginia, a plaintiff must prove damages with “reasonable certainty,” and evidence concerning lost future income or loss of earning capacity must be “grounded upon facts specific to the individual whose loss is being calculated.”  Bulala v. Boyd, 239 Va. 218, 233 (1990).  The  defendants argued that the testimony was speculative because the experts’ opinions were based on generalized employment and earnings statistics about the population at large rather than facts specific to the plaintiff.   Nevertheless, Judge Jones allowed the testimony, holding that it was based sufficiently on facts specific to the plaintiff because it was based on (1) the plaintiff’s  academic reports and medical records; (2) a neuropsychologist’s evaluation of the plaintiff; (3) the plaintiff’s family’s education and vocational background; and (4) a diagnostic interview with the plaintiff and her parents.  Judge Jones’ ruling on this issue is sure to be regularly cited by the plaintiffs’ bar in future cases involving injuries to minors.

Evidence of Other Incidents

Judge Jones excluded evidence concerning two prior accidents involving child safety seats manufactured by the defendant.  In finding the evidence inadmissible and granting the defendants’ motion in limine, Judge Jones analyzed (1) whether the defect in the prior incidents were the same or similar to that alleged in the instant case, and (2) whether the circumstances of the earlier incidents were “substantially similar” to the instant case.  See Musick v. Dorel Juvenile Group, Inc., No. 1:11cv05, 2011 U.S. Dist. LEXIS 122363 (W.D. Va. Oct. 22, 2011) (citing Benedi v. McNeil-P.P.C., Inc., 66 F.3d 1378 (4th Cir. 1995) and General Motors Corp. v. Lupica, 237 Va. 516 (1989)).  Judge Jones concluded that the prior incidents were not substantially similar to the  laintiff’s incident, and that evidence of such incidents presented a strong possibility of unfair prejudice to the defendant.

Spoliation

Defendants moved to dismiss the case as a sanction for plaintiff’s failure to preserve the vehicle plaintiff was riding in at the time of the accident.   Judge Jones denied the motion, finding that there was no evidence that the plaintiff’s parents “willfully or intentionally failed to preserve the vehicle,” and therefore had not “acted with the requisite degree of culpability” to warrant dismissal.  See Musick v. Dorel Juvenile Group, Inc., No. 1:11cv05, 2011 U.S. Dist. LEXIS 122580, at *4-5 (W.D. Va. Oct. 24, 2011).  Judge Jones distinguished the case from Silvestri v. Gen. Motors Corp., 271 F.3d 583 (4th Cir. 2001) by noting that in the instant case, unlike Silvestri, there was no reason for the plaintiff’s parents or attorney to believe that the automobile should have been preserved.  Id. at *5-6 (“Given that no other passengers were seriously injured in the accident, it was not egregious for the Musicks to believe that the child safety seat was the only product necessary to preserve for litigation”).

Discovery Sanctions

Judge Jones also upheld U.S. Magistrate Judge Sargent’s pretrial discovery sanction barring Dorel from presenting evidence as to why it chose not to add foam to the side wings of the child safety seat at issue.  See Musick v. Dorel Juvenile Group, Inc., No. 1:11cv05, 2011 U.S. Dist. LEXIS 126347 (W.D. Va. Nov. 1, 2011).  In this regard, Judge Jones stated:  “the false information provided by defense counsel about his client’s decision not to add foam padding to the side wings of the car seat was significant and justified the sanction, even assuming that the misrepresentation was inadvertent.”  Id. at *2.

 The court sustained Venture Supply’s demurrer on the following counts:  misrepresentation regarding the drywall, willful violation of the Virginia Consumer Protection Act (“VCPA”), negligence per se, breach of express and implied warranties, private nuisance, unjust enrichment, breach of contract, refusal to repair, and damages, including personal, monetary, physical, mental, and emotional, and property, economic loss, loss of use and enjoyment, treble damages, attorneys’ fees, and revocation of licenses. 

 Notably, the Court held that the VCPA did not apply to this case because the construction and sale of the plaintiffs’ house occurred prior to 2011, and the VCPA in effect prior to the 2011 amendment did not apply to Chinese drywall.  Accordingly, the court sustained Venture Supply’s demurrer to Plaintiffs’ VCPA count.  Id. at 8.

 The court also held that Plaintiffs had not alleged any facts regarding warranties made or implied by Venture Supply to support any claim for breach of express warranty.  The court, however, questioned whether Venture Supply was subject, either by the Uniform Commercial Code or otherwise, to implied warranties, including the implied warranty of fitness for a particular purpose, but noted that this issue was not addressed in the demurrer briefs or arguments.  Id. at 9.

 The Court sustained Venture Supply’s demurrer to Plaintiffs’ breach of contract count and claim for economic losses because Plaintiffs did not have a contractual relationship with Venture Supply.  Id. at 10. 

 As for plaintiffs’ negligence claims, the court determined that Plaintiffs had not alleged any violation of statutory or common law duties owed to Plaintiffs by Venture Supply.  “With no such duties, there is no tort claim.”  Id. at 11.

 The Court concluded that Plaintiffs “failed to state a cause of action against Venture Supply,” sustained Venture Supply’s demurrer as to all counts, but granted Plaintiffs leave to amend their complaint.  Id.

 Although this was a favorable decision for a product supplier, Venture Supply likely has not seen the end of this case.  Plaintiffs should be able to amend their complaint to plead a valid claim against Venture Supply.  In Virginia, product distributors, wholesalers and retailers are liable for injuries caused by defects in products they sell because every seller impliedly warrants the merchantability and fitness of a product.  See Featherall v. Firestone Tire and Rubber Co., 219 Va. 949, 252 S.E.2d 358 (1979).  A contractual relationship between the product supplier and the plaintiff is not required for such a claim.  Plaintiffs in the Seeman case will only have to allege that Venture Supply sold drywall that was unreasonably dangerous for either the use to which it would ordinarily be put or some other reasonably foreseeable use and that the unreasonably dangerous condition existed when the drywall left Venture Supply’s hands to successfully state a claim for breach of the implied warranty of merchantability.  Unfortunately for Venture Supply, its victory on demurrer may be short-lived.