Rx-to-OTC switches could be boon as FDA looks at switch paradigm

A new report by Francesco International identified $35.7 billion worth of potential Rx-to-OTC switches in a wide range of indications, from hypertension and chronic obstructive pulmonary disorder to high cholesterol and erectile dysfunction, and the Food and Drug Administration has been looking at ways technology and pharmacists could be employed to ensure that patients taking drugs new to the consumer health space take them appropriately.

With growth in traditional pharmaceuticals expected to slow down significantly, a growing number of drug makers — branded and generic alike — see specialty drugs as their main sources of revenue for the foreseeable future. At the same time, those drug makers not invested in specialty may be looking for growth opportunities in consumer health.

Indeed, while much was made of how Pfizer gained control of Wyeth's specialty drug business when it acquired that company in 2009, or how Merck got Schering-Plough's specialty business in the same way, both mega-deals also turned Pfizer and Merck into consumer health companies, as Wyeth and Schering-Plough had a significant presence in the space. And while Sanofi's acquisition of biotech giant Genzyme got plenty of attention, equally important was when the French drug maker — already a player in the OTC space — purchased OTC maker Chattem.

The FDA's Nonprescription Safe Use Regulatory Expansion initiative could soon open the door to a whole new world of OTC opportunities for traditional drug makers. According to Francesco's report, more than half of patients with hypertension don't have their condition under control, and people with diabetes and COPD face similar problems.

At the same time, Rx-to-OTC switches have often been tricky to accomplish. While switches for antacids and allergy drugs have been relatively easy — Zegerid and Allegra stand out as recent examples — Merck's efforts to get an OTC switch for its cholesterol-lowering statin Mevacor were unsuccessful. Meanwhile, some local and state governments have sought OTC-to-Rx switches for drugs with pseudoephedrine in an effort to stem problems with methamphetamine abuse.

A major issue, however, has been concerns about safety and whether patients can be trusted to self-diagnose and use certain drugs appropriately. A patient taking a prescription drug does so under the watchful eyes of a prescriber and a pharmacist, but a patient taking OTC medications doesn't get that kind of scrutiny and must therefore often determine independently when it's a good time to take the drug and how much to take. 

That helped sink the efforts to get Mevacor switched, as FDA officials decided that patients could not be trusted to know when and when not to use the drug. According to one study that appeared in 2008 in the New England Journal of Medicine, 30% of patients who thought they needed Mevacor in fact had a risk of a heart attack or other cardiovascular problems of less than 5%. More recently, in November 2012, the FDA's Nonprescription Drug Advisory Committee voted 6-to-5 to advise against an OTC switch for Merck's overactive bladder patch Oxytrol, saying that consumers would have a difficult time self-diagnosing an overactive bladder, that symptoms of the condition could indicate more serious diseases like diabetes, and that men might inappropriately choose to use it as well.

In September 2012, a study sponsored by CVS Caremark and published in the Journal of the American Medical Association found that consumers heard less about risks when prescription drugs were switched to OTC, as advertisements for OTC versions of the drugs had significantly less information about potential risks, with only 11% of them discussing the risks, compared with 70% of ads for prescription-only drugs.

Nevertheless, the FDA continues to actively look at OTC switches —  in September 2012, Kalorama Information reported that many applications for switches were under review at the agency, including categories new to the consumer health space, such as bacterial infections, cholesterol and hypertension. And in March 2012, Center for Drug Evaluation and Research director Janet Woodcock told attendees of a conference on OTC switches that the agency wasn't looking to change the switch process itself, but to see how it could incorporate technology and pharmacists into efforts to improve access, such as instructional videos, and requirements for a pharmacist consultation or diagnoses before patients could receive certain nonprescription drugs.

While safety is and ought to remain a top concern, allowing easier access to certain medications while ensuring they use them appropriately could help patients keep certain conditions under control more conveniently while also presenting a huge opportunity for retail pharmacies to boost sales in their OTC aisles and possibly get more attention for their pharmacists as well.