“Behind-The-Counter” Drug Switches Must Tackle Restrictions On Use For Generics

Commissioner Hamburg says FDA asked for input on a “new paradigm” for nonprescription drug approvals in part because pharmaceutical firms have concerns about whether potential access restrictions imposed on an innovating switch would also apply to generic versions that eventually reach the market.

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 (Also see "FDA Digs Deeper On “New Paradigm” To Expand Rx Switches" - Pink Sheet, 5 Mar, 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 (Also see "Pharmacists See Challenges, Opportunities In Behind-The-Counter Class" - Pink Sheet, 2 Apr, 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, held 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.”

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