Drug Industry Daily - April 7, 2011 Issue

Vol. 10 No. 69

FDLI Panel: Drugmakers Shouldn’t Wait Around for Social Media Guidance

With no target set for release of a guidance on social media and internet marketing, drugmakers need to look to other sources and use their own judgment, according to a panel of experts at the Food and Drug Law Institute’s annual conference Wednesday.

The internet evolves faster than the FDA can regulate, said Jeffrey Wasserstein, an attorney with Hyman, Phelps & McNamara.

Jeffrey Senger, a partner at Sidley Austin, agreed and mentioned past comments by the FDA that any guidance the agency produced would be outdated as soon as it was issued and could even “stifle innovation.”

However, lack of a guidance document does not mean companies are completely in the dark on social media, the panelists agreed, though they declined to speculate on when industry might finally get the long-awaited guidance.

“I have some sympathy for the agency,” Senger said. “This is a tricky issue and there are a lot of competing interests that are hard to resolve and they’re trying to coordinate within the regulated communities.” 

“And other agencies are chiming in with their own perspective,” he added. “So, I’m not surprised the date has slipped and it takes a while longer.”

The FDA has also reiterated its concern with “message, not the medium,” a statement that exasperates many who feel that print and broadcast guidelines often don’t apply to new media (DID, April 4). But the basics of those guidelines really do apply to internet marketing, panelists said, even if the medium creates additional challenges.

If you are providing content or paying for it in any way, the FDA will likely treat that content as promotional and regulate it, according to Glenn Byrd, senior director of regulatory affairs at MedImmune.

Stacey Ferguson, a senior attorney in the division of advertising at the FTC, agreed, adding that content produced by bloggers and tweeters who receive any sort of compensation for their work, no matter the form or amount, will be regulated.

The most important thing in this regard, according to Wasserstein, is to “not be a sock puppet,” adding, “It’s about transparency.”

Ferguson agreed that disclosure is paramount. For platforms like Twitter that limit the number of characters in a message, companies or third parties can signal the promotional nature of messages with hashtags such as #ad or #sponsor.

In general, Byrd said, drugmakers should ask themselves several fundamental questions about any promotional materials, on the web or otherwise:

  • Is it truthful and nonmisleading?
  • Is risk information prominently displayed?
  • Does it separate product information from disease awareness?
  • Does it contain all material information to make a decision about using or prescribing the drug?

Drugmakers can also look to guidance from the FTC. While that agency does not directly regulate drug communications, it does have more current advertising guidances that directly address internet marketing.

With the FTC, too, the “net impression of the ad” is the most important matter, Ferguson said. “Consumers need to know when they are being pitched to,” she added.

In general, drugmakers should ask themselves what they’re trying to achieve with a particular piece of communication, Byrd said. The FDA has provided guidance on separating branded and unbranded communications, he added, and drugmakers should take advantage of social media for unbranded uses.

For instance, the communal nature of most social media platforms makes them great sources for market research.

“Social media is mainly about communities of people seeking to have conversations amongst themselves.” Byrd said “People want to hear from their peers; they don’t want to be talked at.”

Social media platforms such as Twitter can also be used for corporate communications, rather than promotion, Senger said.

One of the most important things companies can do is get personnel from multiple departments involved.

“Get everyone in same room talking,” Wasserstein said. “Have a lawyer and regulatory person in the room with marketing and social media people so you know what’s doable.” — Wilson Peden


CDER Boosts Role of Office of Surveillance and Epidemiology

CDER has reorganized its Office of Surveillance and Epidemiology (OSE), elevating it to oversee six separate regulatory and technical staff groups.

OSE will become a super office, or one that houses subordinate offices including the executive operations and strategic planning staff, regulatory science staff, regulatory affairs staff, program management and analysis staff, project management staff and technical information staff, according to a notice in today’s Federal Register.

OSE will also include the Office of Medication Error Prevention and Risk Management (OMEPRM) and the Office of Pharmacovigilance and Epidemiology (OPE).

The OMEPRM will consist of the Division of Risk Management and the Division of Medication Error Prevention and Analysis.

The OPE will include the Division of Epidemiology I and II and the Division of Pharmacovigilance I and II.

Under the restructuring, the business process improvement staff, regulatory policy staff and review management staff will be consolidated into the OSE Immediate Office.

The restructuring aims to provide “greater management support to the growing staff and their many and varied responsibilities,” CDER Director Janet Woodcock, says in a March 4 memo to FDA staff. “We need an organizational structure that provides adequate management support for these vital program areas.”

Woodcock adds OSE plays a critical role in safeguarding drugs once they are on the market and has developed new organizational strength to successfully meet the ongoing challenges of postmarket drug safety and drug lifecycle monitoring. She adds over the last five years OSE has grown in size, acquiring a staff with a broad range of scientific and technical expertise.

Woodcock says CDER will commence a nationwide search for a new OSE director. In the meantime, Gerald Dal Pan, the office’s current leader, will be the acting director. — Molly Cohen


Cephalon Rejects Takeover Bid, Valeant Goes Hostile

Following Cephalon’s rejection of Valeant Pharmaceuticals’ unsolicited proposal to purchase the company at $73 per share, Valeant has responded by going hostile with its bid.

Cephalon’s board of directors said late Tuesday they rejected Valeant’s offer after an analysis from its financial and legal advisors found the proposal “inadequate” and “not in the best interests of Cephalon’s shareholders.”

Cephalon says Valeant’s offer does not fully reflect its standalone value, is based on “worst-case scenario,” is “opportunistic” and gives no value to the company’s pipeline.

In response, Valeant suggested replacing Cephalon’s board with seven new directors in a preliminary consent solicitation statement the company filed with the SEC to directly get shareholder support. 

Valeant offered to take over Cephalon for $5.7 billion, at $73 per share. Analysts were split over how the deal, if accepted by both companies, would play out. Although Jefferies analyst Corey Smith said he expected Valeant would slash Cephalon’s spending and sell off its pipeline, he also advised owners to take the offer since another bidder is unlikely and pipeline events are a year away. Barclays weighed in saying the price was reasonable. Meanwhile, Buckingham Research Group said the offer was weak, and suggested a price of $119 per share (DID, March 31).

In a Tuesday letter to Valeant’s CEO J. Michael Pearson, Cephalon CEO J. Kevin Buchi said, “From the standpoint of the Cephalon shareholder, a transaction with Valeant at this time and at the price you proposed would mean foregoing the greater value obtainable from Cephalon’s strategic plan, including the value inherent in our diversified and robust portfolio of marketed and pipeline products,” he added

“Valeant is going directly and immediately to Cephalon stockholders by initiating its consent solicitation process,” the company said in justifying its hostile bid. “It is Valeant’s expectation that a new Cephalon board would act in the best interests of Cephalon stockholders and remove the impediments to a tender offer and permit Valeant to conduct a due diligence investigation.”

Following a due diligence investigation, Valeant said it may be able to modestly increase its offer price.

“Valeant is committed to enabling stockholders to decide whether to accept this offer,” the company said. “We stand ready to quickly commence and close our transaction as proposed, unless Cephalon stockholders do not support our offer, in which case we will focus our attention on other opportunities to invest our capital.”

There are unlikely no other potential suitors vying for Cephalon, Cowen analyst Eric Schmidt told DID, noting that other possible buyers have probably already evaluated the company.

“My guess is that another buyer is unlikely to emerge and that this company is eventually sold to Valeant,” he added. “I still think a deal in the $75-$80 range is likely.”

Valeant said it planned to submit a notice of its consent solicitation to Cephalon’s corporate secretary Wednesday morning. Following SEC approval, Valeant will make the solicitation available to Cephalon stockholders who will then be able to give written consent for Valeant to replace Cephalon’s board. The Cephalon board has set April 8 as the record date.  — Molly Cohen


Fabry Patients Again Petition NIH for Fabrazyme Open License

Fabry patients have continued their quest to find an alternative producer of Fabrazyme as its manufacturer, Genzyme, endures further manufacturing woes for the drug.

A group of eight Fabry patients petitioned the NIH Tuesday, saying the agency should use its march-in rights under the Bayh-Dole Act to grant an open license on its patents. Fabrazyme, an orphan drug once produced at Genzyme’s troubled Allston, Mass., plant, was developed under an NIH grant.

“For almost two years, no patients in the U.S. have been given the prescribed dosage due to the patentee’s and licensee’s inability to produce enough drug to treat all of the Fabry’s patients that have been prescribed Fabrazyme,” the petition states.

The NIH declined a similar request on Dec. 1, 2010 following an August petition from three Fabry patients (DID, Aug. 4, 2010). But the patients and their attorney renewed efforts after Genzyme announced it stopped production of the drug when a finished batch failed to meet release criteria (DID, March 24).

“For the U.S. patient community, while there may be some supply delays during the month of May, it is important to note that we have not reduced the amount of Fabrazyme they are scheduled to receive,” Genzyme spokeswoman Lori Gorski told DID. “In fact, earlier this year, we began to provide Fabrazyme therapy to a limited number of new patients in the U.S.”

In June 2009, Genzyme reduced the dose for all patients to less than a third of the required dose and banned newly diagnosed patients from receiving Fabrazyme, according to the petition. The company increased the dose to 50 percent earlier this year before its latest production woes.

The NIH has stated FDA regulations prevented another manufacturer from entering the market in time to remedy the shortage as part of its reasons for denying the petition last year, according to the patients’ attorney, C. Allen Black. Also, drugmakers weren’t prevented from conducting clinical trials under the safe harbor provision of the Hatch-Waxman Act.

In January, Genzyme said Fabrazyme supplies aren’t likely to be on track until a new production facility in Framingham, Mass., comes online later this year (DID, Jan. 13).

The patients also filed a lawsuit in Pennsylvania federal court early last month seeking financial retribution from Genzyme for damages relating to the lower Fabrazyme doses.

“We know this is a difficult time for the patient community and we share a common goal of returning to full supply of Fabrazyme as quickly as possible,” Gorski said. — David Pittman


Shire Files Lawsuit Over Watson’s Adderall XR ANDA

Shire, the maker of the attention deficit hyperactivity disorder (ADHD) drug Adderall, has filed a patent infringement and breach-of-contract lawsuit against Watson Pharmaceuticals following the company’s ANDA filing for generic Adderall XR.

The company claims Watson’s selling of an Adderall XR (mixed salts of a single-entity amphetamine) generic would violate three of its patents for the drug, ‘148, ‘096 and ‘768. The case was filed in federal court in the Southern District of New York, Shire said Wednesday.

Shire, which says it holds roughly 25 percent of the ADHD market, generated $361 million in Adderall XR sales in 2010, a steep drop from $627 million in 2009 and $1.1 billion in 2008. The company said in SEC filings that the launch of authorized generics contributed to the decline.

Teva Pharmaceutical and Impax Laboratories began shipping authorized generic versions of Adderall in 2009.

Sandoz reached a settlement with Shire in 2009 allowing it to begin marketing Adderall after it receives FDA approval (DID, Oct. 15, 2009). Under the agreement, Sandoz would pay Shire a royalty from drug sales.

Shire also claims in its lawsuit that Watson violated existing licensing agreements established in November 2007, following an ANDA for generic Adderall XR Watson filed in 2006.

Adderall XR was approved in October 2001 as a once-daily treatment for children ages 6 to 12 with ADHD. Adults were added in 2004 and adolescents in 2005.

Shire’s patents for the drug don’t expire until October 2018 and April 2019, according to the FDA’s Orange Book. — David Pittman


FDA Hands Warning Letter to Chinese API Manufacturer Ningbo

The FDA has handed active pharmaceutical ingredient (API) manufacturer Ningbo Smart Pharmaceutical a warning letter for “significant deviations” from current good manufacturing practice (cGMP) requirements.

During an October 25 to 29, 2010, inspection of Ningbo’s Ningbo, China, facility, the FDA found the company had approved the release of product without first testing it for organic volatile impurities (OVI).

Ningbo reported that the products’ OVI levels conformed to guidelines, but the FDA discovered Ningbo had not in fact performed any tests. “It is essential your firm only report results to customers when you have actually performed the analysis,” the FDA says in a March 30, 2011, letter posted online Tuesday.

Ningbo’s lack of testing “raises concerns regarding the reliability and integrity of other data generated by your firm,” the FDA adds.

The warning letter also notes Ningbo’s quality control unit (QCU) released a number of API lots without first performing required tests. “It is a basic responsibility of your QCU to ensure that all API lots produced meet specifications for quality and purity prior to being released,” notes the FDA.

The FDA further criticizes Ningbo’s data retention practices, or lack thereof. After the agency’s inspection found Ningbo “destroyed some old, but foundational records” the FDA recommended Ningbo, “reconsider your record retention policy for application-related records.”

Due to the severity and number of cGMP problems found during its inspection, the warning letter “highly recommends” Ningbo hire a third-party auditor to assist the company with cGMP compliance.

Ningbo Smart did not respond to a request for comment by press time.

The Ningbo warning letter can be found at www.fdanews.com/ext/files/ucm249425.pdf. — Kevin O’Rourke

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Reporters: Virgil Dickson, Wilson Peden, Molly Cohen, David Pittman, Kevin O'Rourke, Sarah Karlin

President: Cynthia Carter; Editorial Director: Pamela Taulbee; Executive Editor: Jonathan Block

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