This week's issue of "The Tan Sheet" tracks a spike in mergers and acquisitions as Schiff Nutrition International buys Airborne, Genomma Lab pushes forward on its unsolicited bid to take over Prestige Brands Holdings and Somaxon seeks a partner to help switch Silenor.

We also look at the latest in an advocacy group’s litigation to expand OTC access to emergency contraceptives and at studies needed to make an anthrax MedKit potentially available for home use. 

Click here for a full table of contents for the April 9 issue. 

"The Tan Sheet" is your source for the most comprehensive and in-depth coverage of the OTC drug and nutritional industries. Start your free trial subscription here -- no credit card required.

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-- Elizabeth Crawford (e.crawford@elsevier.com)

"The Tan Sheet" is your go-to source for coverage and analysis of FDA's proposed "new paradigm" for approving nonprescription pharmaceuticals under conditions of safe use. See below for a sample of our extensive coverage of the agency's recent public hearing.

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New Paradigm Needs Clear Switch Criteria, Standard Dispensing Rules

by Elizabeth Crawford (e.crawford@elsevier.com)  

“The Tan Sheet” Apr. 2, 2012, Vol. 20, No. 14

 
FDA should address concerns associated with consumers’ substantial role in self-care and the potential benefits of pharmacist oversight when developing the criteria to identify candidate drugs for nonprescription status under a potential new paradigm for drug approvals, health care experts say.

The agency intends to consider on a case-by-case basis what types of drugs can be made nonprescription if additional “conditions of safe use,” such as information technology or intervention by a pharmacist, are applied to help consumers appropriately self-select and use the products.

While each case will be unique, several health care leaders who presented at a public hearing March 22-23 in Silver Spring, Md., suggested FDA should standardize criteria for determining a drug’s switch potential under a new paradigm as well as processes for ordering and dispensing the drugs once they are switched.

The new criteria should expand on current OTC switch standards, but also take into account the added self-care burden placed on patients and the beneficial role of pharmacists, said Cynthia Reilly, director of the Practice Development Division of the American Society of Health-System Pharmacists.

Specifically, she suggests switch candidates under the new paradigm should:

1. Have a well-established benefit-to-risk ratio
2. Have a wide safety margin
3. Not be systemic or an anti-infective agent about which emergency resistance is a concern
4. Have a long marketing history as an Rx product in a large patient group to determine serious side effects
5. Have evidence of efficacy and safety at the dose proposed for switch
6. Be used for a condition that is readily detected by a patient or provider
7. If necessary, require a level of lab work or monitoring by a pharmacis.
8. Have reliable early warning signs that a pharmacist or patient can readily detect if toxicity can result in death or serious harm.

The products also should have uncomplicated instructions for use, said Marissa Schlaifer, the Academy of Managed Care Pharmacy’s director of pharmacy affairs.

She suggested FDA standardize dispensing and record-keeping requirements to include:

1. Adding information about the products and the patient’s use of them to the patient’s medical record
2. Standard clinical evaluation and interventions that pharmacists can follow prior to dispensing the drug
3. Training on the selection of appropriate medicines and monitoring requirements
4. How to protect patient health information
5. When to refer patients to physicians or other health care professionals.

Other presenters at the meeting also noted a new paradigm for nonprescription approvals should require that pharmacists are reimbursed for their additional services, and that pharmacists likely would need additional liability coverage.

Health care industry experts' comments to FDA show that clearing alternative routes to nonprescription status will encounter bumps and generate concerns, as you’ll read in the April 2 issue of “The Tan Sheet.”

At a public hearing on ideas about making more drugs available nonprescription but “under conditions of safe use,” stakeholders questioned whether some prescription "antidotes" should be switched to restricted nonprescription status, and noted that  drug firms likely will not invest in novel switches without market exclusivity and a requirement to make generics also subject to consumer access restrictions. 

In this issue we also report on the Health Choices Coalition urging Congress to support legislation that would strike the health care reform law requirement that consumers obtain a prescription in order to purchase OTCs with a pre-tax savings account.

For much more, and "The Tan Sheet's" April 2 table of contents, click here.

"The Tan Sheet" is your source for the most comprehensive and in-depth coverage of the OTC drug and nutritional industries. Start your free trial subscription here -- no credit card required.Your company or organization may already provide access to "The Tan Sheet." To find out if you should have access, email custcare@elsevier.com.

Also, follow "The Tan Sheet" on Twitter and Facebook.

-- Malcolm Spicer (m.spicer@elsevier.com)

The March 26 issue of "The Tan Sheet" offers a front-row view of last week's FDA public hearing on the proposed "new paradigm" for nonprescription drug access.

We've got in-depth coverage and analysis of what agency officials think is needed to expand the possibilities for OTC switch, as well as what major industry players like GlaxoSmithKline could bring to the table.

This week's edition also looks at Procter & Gamble's "New Chapter" in consumer health products, what OTC firms should know about social media and why adolescent consumers have such a hard time obtaining emergency contraception.

For much more, and "The Tan Sheet's" March 26 table of contents, click here.

"The Tan Sheet" is your source for the most comprehensive and in-depth coverage of the OTC drug and nutritional industries. Start your free trial subscription here -- no credit card required.

Your company or organization may already provide access to "The Tan Sheet." To find out if you should have access, email custcare@elsevier.com.

Also, follow "The Tan Sheet" on Twitter and Facebook.

--Dan Schiff (d.schiff@elsevier.com)

"The Tan Sheet" is your go-to source for coverage and analysis of FDA's proposed "new paradigm" for approving nonprescription pharmaceuticals under conditions of safe use. In advance of the agency's March 22-23 public hearing, check out the below story on what innovative switches could mean for drug innovators and their generic counterparts.

Get the most in-depth reporting on the OTC pharma and nutritional industries in "The Tan Sheet." Your free trial subscription begins here -- no credit card required.

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FDA To Tackle Critical Generics Issue In Switch Paradigm Debate

by Malcolm Spicer (m.spicer@elsevier.com)

"The Tan Sheet," March 12, 2012, Vol. 20, No. 11

In its approach to developing a “new paradigm” for nonprescription switches, FDA is working on addressing a significant concern for potential sponsors: protecting innovators from potentially unfair generic competition.

FDA is collecting input on developing alternative routes to nonprescription drug approvals in part because pharmaceutical firms have expressed concerns about whether sponsors of innovative switches could be assured generic competitors would be subject to the same voluntary restrictions and rules as the innovator, Commissioner Margaret Hamburg says.

The agency is conducting a public hearing March 22-23 to consider how the agency could make nonprescription drug approvals contingent on “conditions of safe use” that would be specific to each product, such as limiting sales to pharmacies, requiring a consumer to confer with a pharmacist about whether a certain drug is appropriate or requiring the availability of a diagnostic technology suitable for use by consumers or pharmacists ("FDA Digs Deeper On “New Paradigm” To Expand Rx Switches" — "The Tan Sheet," Mar. 5, 2012).

While FDA could theoretically grant a firm an approval for a drug with certain voluntary restrictions, such as behind-the-counter sale, current law leaves sponsors with little incentive to innovate in this way.

As the law now stands, “the generic competition wouldn’t have to” comply with the innovator’s voluntary restrictions, Hamburg noted March 7 during a roundtable discussion. “They could just have ‘nonprescription drug’ in their fact box and that would be it.”

She noted FDA is considering whether it can expand the definition of nonprescription drugs to include requiring “conditions of safe use.”

Under such an expanded regulatory scheme, if FDA deems safe use of a drug means any additional conditions of use would be needed, “we need to be able to require it to be attached to any drug that would be a nonprescription drug like that.”

Lawyers and researchers note that generic drugs must have the same labeling as the originating products, but any restrictions on consumer access to a nonprescription drug that are not stated on the product label would not carry over to generics.

“It’s all going to be determined by what is or what is not in the labeling,” one attorney said.

Voluntary restrictions would not “be part of the evidence base for a switch,” said Bill Soller, professor and executive director of the Center for Consumer Self Care at the University of California, San Francisco, School of Pharmacy.

Any restrictions not stated on the label are “things that FDA can’t regulate … require or enforce,” Soller said.

FDA likely would need new authority to establish some type of intermediate status, via enabling legislation.

“That’s one of the big questions,” the food and drug attorney said.

Former FDA chief counsel Peter Barton Hutt of Washington-based Covington & Burling said FDA does not have authority to establish a third class to impose access restrictions on nonprescription products. But a third class is needed to facilitate switches for some drugs, and the agency is making that clear, he added.

“FDA is saying to industry … ‘The only way you’re going to do it is to use some sort of third class mechanism. And if you don’t agree … then forget it,’” Hutt said.

FDA, meanwhile, is keeping an eye on congressional interest in the topic. Center for Drug Evaluation and Research Director Janet Woodcock said Feb. 29 at the International Conference on Drug Development in Austin, Texas, that the alternative routes to nonprescription approvals that FDA is considering could be included as part of the bill to reauthorize the Prescription Drug User Fee Act.

Industry Input

In addition to voicing concerns about generic competition, Hamburg said the pharma industry has encouraged FDA to consider how social and other electronic media could help make more Rx drugs available nonprescription. The firms described “all the new kinds of technologies that are probably going to be in place in pharmacies,” she said.

New technologies could, “for example, help consumers walk through a decision tree, provide them with information, they could watch a video, they could do all kinds of stuff that could in fact enhance their ability to both choose the appropriate drug for them, self-diagnose their condition and then help them use the drug properly,” she said.

Similarly, FDA learned from the pharmacy industry that pharmacists are interested in helping facilitate expanded nonprescription access to drugs.

“It became clear that they have a wonderful resource in the person of the pharmacist. If, in fact, some nonprescription drugs’ condition of safe use would be to consult a pharmacist before you get it, that could also enhance peoples’ ability to use nonprescription drugs,” Hamburg said.

More Questions Than Answers

But compensation for pharmacists’ additional work is a question stakeholders and FDA would have to address, Woodcock observed during the briefing ("Pharmacists See Challenges, Opportunities In Behind-The-Counter Class" — "The Tan Sheet," Apr. 2, 2007).

“There are many questions,” she said, adding, “If this were pharmacist-driven, then how would reimbursement happen? Would patients have increased out-of-pocket costs?”

Soller pointed out that drug manufacturers’ hesitancy about restricted-access switches also could stem from pharmacies promoting generic Rx drugs over brand names. A firm invests in studies and in applying to FDA for a switch knowing it will lose exclusivity eventually, but the loss of market share to store-brand products could be accelerated by pharmacies.

“The whole pharmacy field is set up to move people to generics,” Soller said, adding, “and that’s going to transfer over to the nonprescription arena.”

Hamburg explained why FDA asked for comment on a “huge range of questions” about a possible class of drugs between Rx and OTC at the meeting at the agency’s White Oak headquarters in Silver Spring, Md.

“This is the beginning of a process and we’re really gathering info. We’re trying to get ideas, trying to get feedback from different stakeholders and we’re trying to think about how we can be both innovative but responsible in terms of our mandate around drug approval. But we think these are discussions that need to start happening as we think about people’s health needs, how to improve access and how to help support the appropriate use of drugs.”

Drug Facts Box Limits Switches

She also referred to the limits of the Drug Facts box on OTC labels. FDA currently decides whether a drug can be available OTC based on consumers correctly self-diagnosing and -treating according to the information in a product’s Drug Facts box.

“If it can’t be fit on that fact box, we can’t take it into consideration,” Hamburg said.

The limitations were vivid in failed switch applications for statins, which “only had the fact box to work with,” she added.

Consumers in self-selection studies “had to be able to read the box on the label and determine that a cholesterol drug was right for them and they were unable to do that. It was clear they needed an enhanced decision-making, counseling, decision tree [or] something because they were not able to work through the logic of whether they had hypercholesterolemia.”

While statins are among the drug types frequently mentioned as switch candidates with “under conditions of safe use” applications, Hamburg said FDA’s notice of public hearing for input is not a proposal for a “vast number” of switches, or even for specific drugs.

“It’s not like this at all. It’s like giving us the flexibility and the tools that people can explore these other ways to make drugs available.”

On Thursday and Friday this week, FDA convenes its highly anticipated public hearing on innovative routes to nonprescription drug status. "The Tan Sheet's" March 19 issue continues to delve into the mechanics behind this "new paradigm" and the challenges ahead.

This week we also check in with Prestige Brands' efforts to resist Genomma Lab's unsolicited takeover bid and GlaxoSmithKline's latest OTC divestments, which did not include weight-loss drug alli.  

Additionally, we've got stories on state anti-meth laws, nutritional marketing to the millennial generation, and Teva Pharmaceutical Industries' legal argument for Plan B One-Step OTC market exclusivity.

For much more, and "The Tan Sheet's" full March 19 table of contents, click here.

"The Tan Sheet" is your source for the most comprehensive and in-depth coverage of the OTC drug and nutritional industries. Start your free trial subscription here -- no credit card required.

Your company or organization may already provide access to "The Tan Sheet." To find out if you should have access, email custcare@elsevier.com.

Also, follow "The Tan Sheet" on Twitter and Facebook.

--Dan Schiff (d.schiff@elsevier.com)

This free story is brought to you by "The Tan Sheet," your source for the most comprehensive and in-depth coverage of the OTC drug and nutritional industries. Start your free trial subscription here -- no credit card required.

Your company or organization may already provide access to "The Tan Sheet." To find out if you should have access, email custcare@elsevier.com.

Also, follow "The Tan Sheet" on Twitter and Facebook.

Consumers Challenge DMAA Safety After DOD Bans Products

by Carolyn B. Phenicie (c.phenicie@elsevier.com)

“The Tan Sheet” Mar. 12, 2012, Vol. 20, No. 11

Consumer class-action complaints alleging false advertising and other consumer protection law violations by manufacturers and retailers of dietary supplements containing the stimulant 1,3-dimethylamylamine are piggybacking on the Department of Defense’s ban of the products.

The two suits were filed Feb. 15 in the U.S. District Court for the Central District of California. Consumer class action lawsuits often follow regulatory action, and California has one of the strongest consumer protection statutes in the country, making it an attractive venue in which to pursue litigation ("Class Action Claims Often Follow Regulatory Action, Industry Litigation" — "The Tan Sheet," Jan. 30, 2012).

In a complaint against GNC Holdings Inc., manufacturer Cellucor Sports Nutrition and Woodbolt Distribution, plaintiff Lynette Bates says the DMAA in C-4 Extreme does not meet the definition of a dietary supplement laid out in the Dietary Supplement Health and Education Act.

Bates and plaintiffs in a separate lawsuit against USPLabs LLC, all California residents, rely on DOD’s decision to ban sales of the product at military exchanges and moves by Canadian regulators to support their position ("U.S. Military Investigates Supplement Ingredient DMAA, Bans Sales" — "The Tan Sheet," Jan. 9, 2012). Neither complaint has been certified with class action status.

DMAA has no established history in the food supply, is not a substance for use in the human diet and is not a concentrate, constituent or combination of vitamin, mineral, herb or other botanical, according to Bates’ complaint filed by the Glancy Binkow & Goldberg firm of Los Angeles and the Abbey Spanier Rodd & Abrams firm of New York.

Bates disputes that any DMAA is a constituent of the geranium plant. She adds even if it were, it would be adulterated. DMAA was not marketed as a dietary ingredient before Oct. 15, 1994, the cutoff established by DSHEA for ingredients that do not require a new dietary ingredient notification, the complaint says.

The filing for a class action alleges violations of California’s Consumer Legal Remedies Act and of the state’s business and professional codes, specifically false advertising and unfair competition; breach of implied warranty; breach of express warranty; and unjust enrichment.

The Bates suit seeks to stop GNC and the other defendants from continuing the allegedly illegal business practices in addition to damages and attorneys’ fees.

NDI Draft Guidance Reemerges

The lawsuit against USPLabs, filed for Govinda Hogan and Catherine Giasone by the Kirtland & Packard firm of El Segundo, Calf., alleges DMAA not only does not meet the criteria established in DSHEA, but also is not a supplement because it does not meet the standards FDA laid out in its NDI notification draft guidance.

“Even if defendant’s DMAA is a dietary ingredient and was marketed as a dietary ingredient in the United States before October 15, 1994, it was not marketed in the same chemical composition or structure as in defendant’s products as clarified in [the NDI draft guidance],” the plaintiffs state.

Industry stakeholders and congressional allies have asked FDA to withdraw the draft guidance; the agency’s apparent ban on synthetic botanicals and the requirement that firms re-file notifications with every product reformulation are among the most common complaints ("Synthetics Stance In NDI Guidance Raises Red Flag For Industry" — "The Tan Sheet," Jul. 11, 2011 and "New Dietary Ingredient Notification Draft Guidance Must Be Withdrawn – CRN and CHPA" — "The Tan Sheet," Dec. 5, 2011).

Hogan and Giasone also allege USPLabs’ product was not prepared, packaged or held in accordance with FDA’s current good manufacturing practices.

USPLabs violated California’s business practices laws – false advertising and unfair competition – and the Consumer Legal Remedies Act, the plaintiffs say. They seek damages, attorneys’ fees and to stop USPLabs from continuing these practices.

The firm March 7 touted five published clinical trials supporting the safe use, when used as directed, of its Jack3d and OxyElite Pro products, which contain DMAA. Dallas-based UPSLabs also cited two other studies conducted on the ingredient alone, saying a total of 102 subjects participated in the seven studies and more than 1 billion servings of DMAA-containing supplements have been consumed.

This week's issue of "The Tan Sheet" looks at what FDA's proposed "new paradigm" for nonprescription drug access might mean for the generic versions of innovative switches, given that current law would allow equivalents to bypass voluntary access restrictions and just go completely OTC. 

Inside, we've got stories on Johnson & Johnson's struggles to return recalled OTCs to market under its consent decree with FDA and congressional supplement boosters considering legislation to bring FDA's new dietary ingredient draft guidance in line with DSHEA if the agency declines to pull back on the controversial document. There's also a feature on supplement firm ChromaDex and its pharma-like approach to product development.

For much more, and "The Tan Sheet's" full March 12 table of contents, click here.

"The Tan Sheet" is your source for the most comprehensive and in-depth coverage of the OTC drug and nutritional industries. Start your free trial subscription here -- no credit card required.

Your company or organization may already provide access to "The Tan Sheet." To find out if you should have access, email custcare@elsevier.com.

Also, follow "The Tan Sheet" on Twitter and Facebook.

--Dan Schiff (d.schiff@elsevier.com)

by Malcolm Spicer (m.spicer@elsevier.com)

“The Tan Sheet” Mar. 5, 2012, Vol. 20, No. 10

Venture capital firm Advent Life Sciences invested in U.K. startup CN Creative Ltd. to try to fundamentally change the OTC nicotine replacement therapy market with an electronic inhaler indicated for smoking cessation.

CN Creative’s promotion of harm reduction – a strategy for decreasing the number of people with diseases or other health problems linked to smoking tobacco, as opposed to strictly targeting cessation of smoking or all use of nicotine – is central to Advent’s interest, the investment firm says.

Advent led CN Creative’s first financing round, which raised $3.1 million (£2 million), the firms said Jan. 25. CN Creative will request regulatory approval for its Nicadex electronic nicotine inhaler as an NRT and already markets EVOlution e-cigarettes in Europe and the U.S. through its Intellicig business.

The timing may be right, though some experts predict that in the U.S., FDA will continue to oppose e-cigarettes and harm reduction. But legal changes have opened FDA more to considering harm reduction indications.

To continue reading this story, click here.

"The Tan Sheet" is your source for the most comprehensive and in-depth coverage of the OTC drug and nutritional industries. Start your free trial subscription here -- no credit card required.

Also, follow "The Tan Sheet" on Twitter and Facebook.

In addition to in-depth coverage of FDA's notice of a public hearing to consider a "new paradigm" for OTC pharmaceutical access, this week's issue of "The Tan Sheet" features stories on an upcoming FDA advisory committee meeting to discuss OTC home-use anthrax MedKits and an electronic cigarette company that aims to make harm-reduction/nicotine-replacement therapy claims.

"The Tan Sheet" also looks at a federal court's ruling that went in favor of supplement firm Garden of Life and against the Federal Trade Commission. We've got updates on Abbott, Colgate-Palmolive and Procter & Gamble, too.

For much more, and "The Tan Sheet's" full March 5 table of contents, click here.

"The Tan Sheet" is your source for the most comprehensive and in-depth coverage of the OTC drug and nutritional industries. Start your free trial subscription here -- no credit card required.

Also, follow "The Tan Sheet" on Twitter and Facebook.

- Dan Schiff (d.schiff@elsevier.com)