FDA November Public Meeting Explores Potential New 3rd Class of Drugs

The US Food and Drug Administration has announced its intention to hold a public meeting on November 14, 2007 to explore the possibility of establishing a 3rd class of drugs, referred to as Behind-the-Counter (BTC) drugs. These drugs could be sold without a prescription but only under pharmacist supervision. Currently, the US has only two classes of drugs, prescription and non-prescription or Over-the-Counter (OTC) drugs. Most other countries have more than two classes of drugs with, for example, France having seven and the UK three classes of drugs.

The FDA is interested in expanding the availability of certain drugs and rightfully questions whether a one new major class of drugs (BTC) is suitable for the United States to expand product choices. The FDA also seeks advice on whether the formal establishment of a BTC class of drugs would indeed improve public health in the US, especially for the approximately 47 million Americans who have no health insurance currently. It is also widely believed that healthcare costs will decline with the combination of decreased drug reimbursement and lower OTC prices.

They have asked for formal opinion from experts with regard to the decisions on the type and criteria of possible BTC drugs, as well as the logistics of administration of BTC drugs.

Francesco International agrees that
• Expanded non-prescription availability is needed in at least 40 therapeutic areas,
• With 9 of special focus and urgency (see later)
Francesco International disagrees that
• There is a need for a new 3rd class of drugs. Rather, Francesco feels the current Rx-to-OTC switch process possesses the mechanisms for a major expansion of Behind-the-Counter classification if used properly and creatively.

Francesco International (a 13 year old pharmaceutical consulting firm that specializes in this area www.franint.com) says that with some adjustments to the existing Rx-to-OTC switch process combined with creativity and a more proactive FDA, many drugs can become available without a prescription and may end up behind-the-counter (BTC) or be over-the-counter (OTC) without going through a long formal process of establishing a new 3rd class of drugs. We have the important example of BTC/OTC status with emergency contraception drugs now in the US as well as with pseudoephedrine and other drugs. In the case of emergency contraception in the US there have been historically between 100,000 and 250,000 unwanted children born each year, most with significant consequences. This is a global issue. Independently, Boards of Health around the world approved the emergency contraception nonprescription status, in Europe in 2003 and the US in 2006.


The following, according to Francesco, are the top 9 classes needing expanded availability, whether in BTC or OTC status, and approvable within the current system’s structure:

Francesco’s Top Nine Growing & Troubling Health Indications
That Should Be Treatable With an Effective & Safe Non-Prescription Drug


1. INCONTINENCE Incidence: >13 million in the US. Fewer than 50% of sufferers receive treatment. 53% of home bound elderly suffer. An effective prevention program with medication as part of the regimen would produce 50,000 fewer new cases of incontinence in community-dwelling women alone, as well as in the general population
2. ASTHMA Incidence: >17 million in US. Up from 6.8 million US in 1980.
Asthma kills some 5,000 US each year.
3. HYPERCHOLEST-EROLEMIA Incidence: >25 million in the US. 20 million receive no treatment.
Lowering LDL cholesterol / raising HDL produces a reduction in coronary event rates of around 35%. BTC Status in the UK
4. HYPERTENSION Incidence: >50 million in US. 47% receive no treatment.
Extremely high incidence in black males over 45 years of age
5. VIRAL INFECTIONS
Incidence: Variable. Usual OTC treatment is symptomatic. Cold sores most common.
OTC curative therapy for cold sores with mild steroids now available in UK other countries.
6. ARTHRITIS Incidence: >43 million in US. 50% receive no treatment. Limited OTC choices. Incidence will increase with aging of the population. The #1 analgesic need for 45+.

7. MIGRAINE Incidence: >23 million in US. Sufferers are 15-30% of all adult women and 5-20% of all adult men. The number two need for an analgesic for 26-45 year old population. BTC status in Germany.
8. BENIGN PROSTATE HYPERPLASIA Incidence: A common condition for men over 50 years of age. Can have a significant impact on health and quality of life. Incidence will increase with the aging of the male population. Drug intervention becoming preferred over surgery.

9. OSTEOPOROSIS Incidence: >25 million in the US. Women 3-8 times more likely to suffer than men.
Responsible for 1.5 million fractures per year. Incidence will increase with the aging of the population.
© 2007 Francesco International

We have also identified another 31 therapeutic categories that could enhance public health via expanded drug availability using BTC/OTC status.

Francesco International says that a data driven assessment of possible switch drugs, creativity and a proactive FDA are enough to meet the FDA’s goals without establishing a new and separate class of drugs.

A more proactive US FDA should include and require periodic drug review and reimbursement justification. In virtually all other countries, the country Board of Health requires a periodic review of those drugs on the reimbursement list. As the review takes place, older drugs are replaced by newer and better ones and those that lose reimbursement are usually swiftly moved

on to another classification by the drug company, often eventually becoming available to consumers via the pharmacy distribution system without a prescription.

Recommendation: The US FDA, perhaps in combination with other interested parties such as managed care and the drug company, should initiate reviews of therapeutic categories and require justification for continuing to reimburse certain drugs. If not justified, the drug company will no doubt move them, if appropriate to BTC/OTC status.

As background, the Rx-to-OTC switch industry is highly regulated and hindered from expansion. The products are sourced from the prescription business only. Moreover, government switch approvals are required that focus around three key challenging questions regarding a switch:
1. Is the drug safe — i.e. are there only a few minor side effects possible and little chance of dangerous drug interactions? Safety is the dominant criteria and safety standards are much higher than for prescription drugs because prescription drugs have a doctor involved and not with OTC. Could a pharmacist be an alternative? We think so.
2. Is the drug effective? Does the drug do what it says it does? Most OTC drugs are designed to treat symptoms and not cure health problems. They are supposed to be used over the short term, usually not more than two weeks. If longer term use is required, could a pharmacist monitor the sufferer’s response and suggest alternatives in certain therapeutic categories. Could cures of selected therapeutic problems be prescribed by a pharmacist? We think so.
3. Can the patient/consumer diagnose (or self-recognize) the problem correctly? In other words, you know that you have a cold, constipation, etc. If not, in certain selected categories, can a pharmacist provide assistance or refer the sufferer to a doctor. We think so.

Without the intervention of “the learned intermediary,” the physician, the FDA enforces extremely high switch standards for safety, efficacy and self-diagnosis. These standards have been difficult for many potential switch products to satisfy. In effect, the currently rigorous switch standards restrict the distribution and wider availability of drugs that could have relieved much suffering. The FDA is now asking whether there could be another way to look at switch.

We think there is. BTC is simply another form of non-prescription status. It is merely using the pharmacist more actively as is the case in most other countries. With a more proactive US FDA, and more creativity in using the current system there can be many more drugs that will be able to reach more of the public with pharmacist help (behind-the-counter) or not (over-the-counter).

We applaud the FDA initiative to review this subject on November 14, 2007.
______________________________________________________________________________
This document was written by Steven Francesco, President of Francesco International
115 Old Short Hills Road, Suite 259, West Orange, New Jersey 07052
Ph: 973-985-0589 Email: Stevef@franint.com.

Mr. Francesco, MBA, has frequently testified at the FDA, and is a regular contributor to numerous news organizations including CBS, NBC the NY Times & Wall Street Journal. He has over 20 years of expertise on major pharmaceutical subjects.