CDER Director Sees Behind-The-Counter Switches As Best Bet

FDA drug center chief Janet Woodcock says behind-the-counter switches would be the most effective method to make Rx drugs available without prescriptions, particularly to help treat chronic conditions.

The Center for Drug Evaluation and Research director floated a trial balloon for reviving discussion of the controversial "third class" of drugs April 5 at the Food and Drug Law Institute's annual conference in Washington.

Allowing behind-the-counter – or pharmacy-only – nonprescription sales of certain existing Rx drugs "would be extremely beneficial," she said. "I've always thought that."

Woodcock's comments will reverberate around big pharma, said switch consultant Steve Francesco.

"I think they'll sit up and take notice. I'm glad she's surfacing that idea," said Francesco, who launched Francesco International in Orange, N.J., after retiring from Schering-Plough.

FDA's interest in BTC nonprescription drugs appears to have waned since the agency conducted a meeting in 2007 to consider public comment after former commissioner Andrew von Eschenbach last floated the third class balloon (Also see "Behind-The-Counter Guidance Stalled, But Interest Grows To Expand Access" - Pink Sheet, 30 Jun, 2008.).

But Woodcock's comments indicate the idea is far from dead at the agency, despite her disclaimer that she is not aware of the agency's "party line" on BTC.

FDA knows "how to use the media," Francesco said.

And FDA may be reviving the topic because the public health outlook has changed since 2007, said Joe McGovern, a pharmaceutical marketing consultant with The Atlantis Group.

The pharma industry, like health care providers and regulators worldwide, realizes that more consumers need access to drugs to prevent or treat chronic conditions such as hypertension, diabetes, obesity and high cholesterol, McGovern said.

"These are time bombs for the health care industry. The health care industry knows they're coming but have no plan to deal with them," he said.

Few Candidates For Safe Self-Selection

BTC status may be necessary to move some drugs to nonprescription status because fewer existing Rx drugs are appropriate for consumer self-selection.

"Most of the easier switches have already happened," Woodcock said, adding, "we're not seeing the kinds of switches we did in the '90s because all of those things were obvious and have already moved over the counter."

She pointed out pharma firms know from research that "the average consumer is not capable to determine whether they have [a certain] problem and then selecting the appropriate medication."

Woodcock and her FDA colleagues likely are frustrated by switch submissions that fail due to consumers' problems with label comprehension, McGovern observed.

"They find it very hard to approve drugs without some sort of collateral thing other than the label. Because of that, she's testing the water on BTC again," he said.

FDA has rejected three proposals by Merck to switch its cholesterol drug Mevacor Daily (lovastatin), most recently in December 2007 when the agency and an advisory committee questioned the drug's OTC safety due to study data showing a degree of inappropriate self-selection among consumers (Also see "FDA Advisors Say Greater Insight Needed On Self-Selection Of OTC Statins" - Pink Sheet, 17 Dec, 2007.).

BTC's Advantages

Woodcock outlined what she considers the advantages of BTC switches.

Pharmacists "actually are the most trained professionals as far as drug use," and increasing their interaction with consumers could help improve adherence to therapies, she said.

Woodcock referred to hypertension and cholesterol treatments as examples of chronic conditions treated with Rx products with histories of poor adherence by patients.

"There is so much non-adherence to really important drugs that affect public health," she said.

"I think it's a shame that we don't do [BTC access] because that might enable more dissemination of medications to populations that are currently non-adherent and would probably help adherence," Woodcock added.

BTC's Challenges

Under existing drug law, FDA cannot require a firm sponsoring a switch application to move a product from Rx to pharmacy-only nonprescription sales.

But sponsors voluntarily can ask the agency for BTC status, as was done in 2006 with the Plan B (levonorgestrel) emergency contraceptive switch. Many experts have suggested sponsor-requested BTC status under a risk management plan as a way to create BTC access without a change in drug law; FDA previously appeared open to considering such applications.

"I think it's a shame that we don't do [BTC access] because that might enable more dissemination of medications to populations that are currently non-adherent." – CDER Director Woodcock

But a law establishing a third class of drugs would be needed before the agency could require pharmacy-only sales. Federal, state or local laws require sales from behind store counters – but not by pharmacists only – of OTCs including pseudoephedrine-containing drugs and some nicotine-replacement therapies. Some states also allow pharmacists to distribute certain Rx drugs without prescriptions.

While Woodcock expects benefits from increasing pharmacists' role in consumers' access to some therapies, McGovern suggests nurse practitioners are better situated to facilitate assessment of a consumer's need for a BTC drug.

In the U.K., a retail pharmacy's dissemination of drugs becomes clogged when pharmacists must take time to assess patients asking for nonprescription, pharmacy-only products, McGovern said.

"Anything more than three or four questions becomes a logistical nightmare," he said, adding that U.K. pharmacists likely will refer a consumer to a doctor before they suggest a drug.

"It's just difficult to see it in practice. The devil is trying to do it in practice."

On the other hand, nurse practitioners are trained to perform the work required for determining a consumer's condition and whether some pharmaceutical treatment is needed.

Nurse practitioners, who often provide services at many in-store clinics operated by drugstore chains, are "underused" in health care worldwide but could "fill an important role in the treatment of chronic diseases," McGovern said.

Paying For BTC

Pharmacists and the Government Accountability Office point out the benefits from pharmacists' increased interaction with patients come at a price.

In a March 2009 report, GAO said pharmacists' roles, responsibilities and any additional pay must be determined for Congress to establish a BTC class of drugs. The report, which updated GAO's 1995 report on 10 foreign countries with some behind-the-counter sales of some OTC drugs, doubted the benefits from a BTC class (Also see "Behind-The-Counter Class Requires Investment, With Payoff Unclear– GAO" - Pink Sheet, 30 Mar, 2009.).

Commenting on a recent Arkansas law requiring an increased role for pharmacists in screening nonprescription PSE sales, pharmacy expert Randy Juhl said pharmacists rarely have time available from preparing and dispensing prescriptions to assess patients' conditions.

Juhl, vice chancellor and distinguished service professor of pharmacy at the University of Pittsburgh, concurs with the GAO conclusion that requirements for paying for pharmacists' diagnoses should be made when products are given pharmacy-only status (Also see "OTC Pseudoephedrine Purchases In Arkansas Require In-State Identification" - Pink Sheet, 4 Apr, 2011.).

Profits From BTC

While questions on how consumer need is diagnosed might seem like an obstacle to approving BTC switches, pharmaceutical firms also look at how switching to pharmacy-only status might impede sales of a drug.

The Plan B switch sponsor volunteered to assign the product to BTC status with an age restriction on sales to facilitate the switch approval, not as a means of driving higher sales than actual OTC status.

McGovern said he commonly discusses the possibility of BTC switch applications with pharma executives. He said a CEO's recent remark is representative of the industry's regard: "Why would I want to halve my sales potential?"

Francesco also finds hesitancy about BTC in big pharma executive suites. "The bigger companies really control the OTC market and this is in a way a barrier to not having a third class of drugs," he said.

It's also a barrier to following a public health model rather than a business model for providing U.S. consumers with pharmaceutical products essential to public health, Francesco added.

A public health model emphasizes making the most treatments available to consumers and is facilitated by having a pharmacy-only class as well as Rx and OTC, as is common in international markets.

The business model, however, emphasizes keeping tight control on the most important and most expensive pharmaceuticals through prescription distribution, and moving some of those products to OTC only after their Rx exclusivity lapses and profits from nonprescription sales can be realized.

But pharma firms' earnings will not wither if they voluntarily ask FDA for a BTC switch, Francesco said. While BTC sales of a product would not rival the potential OTC revenues, the nonprescription safety record a product builds through BTC sales could help move the product eventually to actual OTC status, and higher sales.

"A third class of drugs is a good idea because we can get more drugs out there efficiently, but we're still going to have some supervision," he said.

And while larger firms appear pessimistic at best about BTC, others could find the option more appealing. "A smaller business could see a third class as a way to gain market share ahead of the bigger guys," Francesco said.

McGovern acknowledged he doubts the revenue potential for BTC products – "I don't think any switch [in the U.K.] that requires a pharmacist's questionnaire has been commercially successful" – but he also expects the time has come in the U.S.

"Somebody's going to ask for behind the counter," he said.

By Malcolm Spicer