FDA will hold a public hearing on a “new paradigm” for drug approvals that “under conditions of safe use” will allow nonprescription access to some categories of Rx drugs for treating chronic conditions.

The questions on which FDA seeks input at the March 22 and 23 hearing in Silver Spring, Md., indicate the agency is delving into greater detail than in previous discussions of a behind-the-counter drug class or other alternative routes to access.

In the meeting notice in the Feb. 28 Federal Register, FDA says it also is considering diagnostic technologies needed for consumers’ safe self-selection, the role of pharmacists and compensation for their increased interaction with consumers and whether some drugs would be available only in pharmacies.

New Drug Paradigm

FDA will hold the meeting March 22 and 23 at its White Oak campus in Silver Spring, Md.
Requests to present at the meeting are due March 9.
FDA seeks information from regulated industry, consumers, pharmacists, physicians, insurers and managed care organizations.
The Consumer Healthcare Products Association and American Pharmacists Association plan to present at the meeting.

The conditions of safe use would be specific to a drug and might require sale in certain settings, such as pharmacies, or require counseling or in-pharmacy diagnostic testing by a pharmacist or by the consumer. The new paradigm also might allow some drugs to be prescribed by a doctor initially but permit consumers to obtain a greater number of refills without additional intervention by the doctor.

Current requirements to obtain a prescription and make one or more visits to a health care practitioner “may contribute to under-treatment of certain common medical conditions” including high cholesterol, high blood pressure, migraines and asthma, according to the notice.

Some of these visits could be eliminated by making certain drugs available without a prescription but with other conditions of safe use, the agency says. Reducing the number of visits to doctors for such treatments would allow health care practitioners to attend to more seriously ill patients, the agency says.

“We’re on a threshold of a next generation of switches, but FDA would need new conditions of approval to do those,” said consultant Joe McGovern of The Atlantis Group.

As opposed to previous switches of drug classes that treated health conditions with obvious symptoms, like headache or seasonal allergies, switches under the new paradigm would treat chronic conditions without obvious symptoms.

Patients would need tests to know if they need the drug and to know if the drug is working, he said. “And that’s new for OTCs. I don’t think it’s insurmountable, and I think it’s very exciting, but it is new,” said McGovern.

The paradigm may be particularly useful for rescue medicines, like inhalers for asthma or epinephrine for allergic reactions, FDA notes.

With a pharmacist’s intervention, some diseases or conditions that might require confirmation of a diagnosis or routine monitoring using a diagnostic test – such as a blood test for cholesterol levels or liver function – could be made available nonprescription in a pharmacy.

However, FDA points out that while certain classes of drugs “may be appropriate candidates for nonprescription use under this new paradigm,” the agency would need to evaluate each new drug application on a case-by-case basis.

FDA raises questions in a number of areas, including specific diseases for which consumers would benefit from this type of paradigm, types of diagnostic testing currently in development, what other conditions of safe use may help ensure safety and the appropriate type of studies to evaluate the safety and efficacy of the drugs and new technologies.

The agency also seeks input on financial concerns – namely, whether elements of such a scheme would raise consumers’ costs, whether it would reduce the burden on emergency rooms and individual health care providers and the impact on insurance companies.

The agency asked similar questions during previous public hearings on the possibility of establishing a third class of drugs, and members of Congress have asked the Government Accountability Office for multiple reports to help determine whether the additional drug approval process is needed Also see "Behind-The-Counter Class Requires Investment, With Payoff Unclear– GAO" - Pink Sheet, 30 March, 2009..

Randy Juhl, a pharmacy professor at the University of Pittsburgh and a former Nonprescription Drugs Advisory Committee chairman, said FDA is revisiting some familiar issues.

“In a lot of ways, there’s not much new. The questions have been analyzed and reviewed before,” Juhl said.

Center for Drug Evaluation and Research Director Janet Woodcock in April 2011 encouraged the pharma industry to submit new drug applications incorporating behind-the-counter distribution or other innovations to allow more Rx switches while ensuring safe use by consumers Also see "CDER Director Sees Behind-The-Counter Switches As Best Bet" - Pink Sheet, 11 April, 2011..

The last time the agency had a public meeting on a third drug class, they did not come out “with a clear direction or a clear mandate from the audience to do anything,” so nothing happened, McGovern said. Pharmacists favored the proposal, doctors opposed it and industry reaction was split, he added.

“I think they’d want some sort of clear signal from industry that yes, they wanted this,” before agency officials feel they had the power to move ahead, he added.

Joseph Papa, CEO of private label giant Perrigo Co. PLC, notes opinions at the meeting likely will be mixed – some presenters will favor the idea while others “think it absolutely will be a disaster,” he said during a Feb. 29 analyst presentation.

Diagnostics At The Forefront

FDA is aware industry is developing technologies to allow consumers to self-screen for a particular disease and determine if a particular drug is right for them. For example, technology offered in pharmacy kiosks or through interactive web sites could lead consumers through an algorithm for a particular drug product, the agency says.

Some diseases or conditions might require confirmation of a diagnosis or routine monitoring using a diagnostic test – like blood tests for cholesterol levels – that could be available in a pharmacy, the agency says. A pharmacist could use the results to determine whether use of a certain drug is appropriate.

“For drugs that require use of a diagnostic test, creating a pathway for nonprescription use may result in the development by industry of diagnostics suitable for use by the patient or a pharmacy professional.”

In-pharmacy blood testing for cholesterol would allow a firm to clear one of the major hurdles in switching statins by aiding consumers’ selection decisions. Switching the drugs may provide a period of nonprescription exclusivity, potentially a blockbuster for firms like Pfizer Inc., whose Lipitor late last year faced generic competition for the first time Also see "Lipitor OTC Switch Would Force Pfizer To Clear Big Research Hurdles" - Pink Sheet, 8 August, 2011..

Three FDA advisory panels have rejected a proposed switch of Merck & Co. Inc.’s Mevacor Daily (lovostatin) cholesterol treatment, most recently in 2007. Following a 2005 vote against recommending approving a switch for the product, a number of panelists said a behind-the-counter option would be the perfect solution for expanding access while ensuring accurate self-selection Also see "Mevacor OTC Panel Rejection Elicits Third Drug Class Talk" - Pink Sheet, 17 January, 2005..

Label changes for all statins, including dropping the need for periodic monitoring of liver function, is reviving discussion of an OTC switch Also see "Statin Label Change Stirs OTC Switch Discussions" - Pink Sheet, 5 March, 2012..

Juhl noted that when FDA considered the Mevacor switch, it required a great deal of data from consumer studies. “The more complicated the data set, the more chances consumers have to screw up and the less useful the product became,” he said. “I don’t know if there’s anything technologically available that would minimize the mistakes people had a tendency to make in that trial.”

“We’re on a threshold of a next generation of switches, but FDA would need new conditions of approval to do those.”

–consultant Joe McGovern

Approval of drugs under such a paradigm may need to include patient studies – including self-selection, label comprehension and actual use studies – to demonstrate a drug’s safety and efficacy. When a device is necessary for safe nonprescription use, “evidence may need to be submitted demonstrating that it will perform its intended function and can be appropriately administered in the particular setting in which it will be used,” FDA says.

McGovern said the current diagnostics system is geared for use in a lab infrastructure in which doctors interpret results for patients. The potential for switches will come with consumer-driven tests that can report results in a way consumers will understand.

Additionally, diagnostic technology is evolving rapidly, he said. Two companies might switch drugs in the same class using different technologies under their conditions of approval, or a company might agree with FDA on original conditions of use but then seek to change them when new technology develops, McGovern said.

Questions On The Pharmacists’ Role

Pharmacists could have an even larger role under the new paradigm than under previously conceived behind-the-counter schemes. Under the paradigm described in FDA’s notice, a pharmacist may be involved in diagnostic testing in addition to counseling on counter-indications or assisting a customer in choosing among various drugs.

During previous discussions, FDA officials raised concerns about pharmacists’ role in the process Also see "Behind-The-Counter Guidance Stalled, But Interest Grows To Expand Access" - Pink Sheet, 30 June, 2008..

Pharmacists’ increasing role in dispensing vaccines may have played a role in FDA’s thought process, Juhl said. “You could view that as a prescription drug that no longer requires a prescription,” he said.

Many states allow collaborative care agreements in which a doctor makes an initial diagnosis and a pharmacist monitors biomarkers like cholesterol levels or blood pressure and assists with education and chronic disease management, Juhl said. Patients often see pharmacists several times a year for refills and a physician only annually, he added.

Under this scheme, “you have the collaboration between the physician and the pharmacist, as opposed to what appears in this draft to be simply a regulatory vehicle that doesn’t really address that relationship,” he said. “You do want to have pharmacists be responsible for moving patients along to a physician when something comes up that is unexpected.”

In its questions to stakeholders, FDA asks whether additional specialized training for pharmacists would be needed, whether it would raise liability concerns for pharmacists and to what extent those concerns raise costs.

Juhl said pharmacists who recently finished their education would be well-equipped to handle the hypothetical duties discussed, but pharmacists who have been out of school longer may need additional training. The profession could handle any additional training internally, he added.

In the last five or 10 years, the profession has transitioned to a doctorate of pharmacy program, requiring six years of education instead of five, said Marcie Bough, senior director of government affairs at the American Pharmacists Association. “There’s extensive training and education within the course of the program and then rotations where we’re out working in practice and with the physicians,” she said.

The National Association of Chain Drug Stores said it is reviewing FDA’s proposal. “It is important to note that community pharmacists are highly trained health care professionals that can assist and counsel patients with their medication regiments,” the group said.

Ultimately, under the new paradigm the extent of pharmacists’ work would depend on whether consumers and insurance providers are willing to pay for the additional time pharmacists would need to spend dispensing drugs, Juhl said. Some costs may be cut by having pharmacy technicians answer simple questions or having consumers use technology to help with diagnoses, he said.

Reimbursement issues are “certainly an obstacle,” said Brian Gallagher, APhA’s senior VP of government affairs. Many pharmacists are so busy with existing duties dispensing drugs that stores would need to hire another pharmacist to provide the new services “in a really robust fashion.”

The marketplace likely will shape the eventual reimbursement model, he said, noting a model for vaccine reimbursement emerged “when people started seeing the value” of pharmacists providing this service, particularly at the height of concerns about H1N1 swine flu.

In Europe, drugs that have switched nonprescription on condition of a completed questionnaire have not been commercially successful, McGovern said. Zocor Heart Pro (simvastatin) has since been discontinued. A pharmacy questionnaire developed in the mid-‘90s for Tagamet (cimetidine) gastrointestinal reflux disease treatment was unsuccessful because often pharmacists did not have enough time to assist consumers, recommended antacids or referred them back to physicians.

“If you have to wait to see a dispensing pharmacist, you’re going to waste time and you’re going to distract them from the busy time of day when they’re dispensing all their medicines,” McGovern added.

Simultaneous Rx And Nonprescription Approval?

The agency also is considering whether the same drug could be available simultaneously as both prescription and nonprescription. Dual availability “could help ensure greater access to needed medications by making obtaining them more flexible,” FDA says.

Some consumers could continue seeing health care practitioners for diagnosis and prescriptions or when a local pharmacy is not equipped to offer the drug nonprescription. Other consumers could obtain nonprescription products “with conditions of safe use” where available.

FDA does not raise questions about whether having a drug available simultaneously Rx and OTC would be confusing for consumers or physicians but does seek input on whether consumers and practitioners may be confused about where they can obtain drugs under this scheme.

The agency traditionally has relied on the Durham-Humphrey Amendment, a 1951 change to the Food, Drug and Cosmetic Act, to support its assertion that absent a “meaningful difference,” a drug may not be marketed OTC and prescription simultaneously, lawyers from Hyman, Phelps & McNamara note in a post on its FDA Law Blog. Historically, those meaningful differences have included differences in active ingredient, indication, strength, route of administration or dosage form; the agency added age as a sixth difference in its approval of emergency contraception, the post notes.

Whether the new paradigm will resolve the issue or add conditions of safe use as a new “meaningful difference” remains to be seen, the attorneys add.

McGovern noted that a change in the law to allow simultaneous Rx and OTC sales would bring the U.S. in line with Japan and much of Europe. In those countries, a switch means the drug is available both OTC and prescription, not like a pure switch in the U.S. when drugs move to OTC and are no longer available Rx, he said.

Show Me The Money

Analysts with Cannacord Genuity say although any changes are a long way off, FDA’s consideration of the new paradigm highlights “what will be a longer-term trend supporting growth in the OTC arena, and certainly something to watch that could have a broader impact on healthcare.”

Favorable demographics and an increasing push from big pharma to reinvigorate old brands will support the shift, the analysts predict in a Feb. 29 note.

Perrigo CEO Papa noted big pharma’s incentive to switch drugs OTC. “Many of these franchise products give you a tremendous annuity … much more than the life of an average branded prescription item where you get a great return, but then after it goes generic you essentially lose 90% day one of the generic,” he said.

Pharma firms do need “a bigger franchise, a bigger portfolio” to take advantage of switch opportunities, he said, pointing to the “fabulous job” Sanofi did launching OTC Allegra after its purchase of Chattem Inc. Also see "Sanofi Allegra Switch Approval Triggers Race To Market For Perrigo" - Pink Sheet, 31 January, 2011..

Perrigo “thinks it’s fabulous when more branded companies get into the OTC space” because it “gives me more targets for the future,” Papa said.

The global OTC market is around $100 million, the Cannacord analysts wrote. In addition to Perrigo, they note Teva Pharmaceutical Industries Ltd.’s aggressive targeting of the global OTC market through its own platform and the PGT Healthcare joint venture with Procter & Gamble Co. make it “best positioned for brand OTC.” Others, like Hi-Tech Pharmacal Co. Inc., also participate in the market, and “we expect others to pursue OTC as a growth opportunity going forward.”

FDA Digs Deeper On “New Paradigm” To Expand Rx Switches

More from United States

More from North America