The role of the pharmaceutical physician in the OTC division of a major pharmaceutical company is substantially different from that played in the research or medical affairs departments dealing with prescription drugs. One might assume that OTC work is simpler and less involved than that related to prescription medications. In many ways, the opposite is true.
The OTC pharmaceutical physician must be a generalist, requiring a broad expertise in medicine, toxicology, and regulatory affairs. The OTC physician deals with a vast variety of drugs from many different areas of medicine, including some that are little taught in formal medical education. This contrasts with research on new chemical entities, where the physician generally focuses on a single therapeutic area, enjoys a large support staff that provide him/her with in-depth assistance, and uses a limited number of research protocols and techniques that can be thoroughly mastered. In contrast, the OTC physician must be an expert on smoking cessation one day, gastroenterology the next, and dermatology the next. The OTC physician must also be concerned with detailed issues of formulation and manufacturing.
The regulations governing OTC medications are substantially different from those in the prescription field, and the OTC physician is typically more involved in regulatory matters than his/her non-OTC colleagues.
Because staff are fewer and the hierarchy simpler, the OTC physician has much more general authority, with broad responsibility for in-line, new, and forthcoming products. On the prescription side, this would not be true of any job short of the Vice President of Research.
Another difference concerns marketing. Typically in the prescription area, interaction with the marketing department is infrequent, although sometimes intense. In the OTC area, it is constant. The physician educates the marketing department on medical issues surrounding a particular drug and on the opportunities and limitations that these present. In particular, the physician must understand the needs of the brand managers and be able to offer guidance. For instance, when difficulties occur in the implementation of marketing plans, the physician must be able to assist in developing alternative strategies. An OTC business is subject to intense market pressures. The physician must help the marketers deal with them effectively by frequently playing the roles of educator and creative thinker as well as medical expert.
One of the most surprising aspects of the pharmaceutical physician's role in OTC medication is the very high degree of creativity required of the physician. With prescription medication, one must work with whatever compounds have been previously developed by chemistry and toxicology. These are brought to the physician for clinical testing. There is seldom any input by the physician into drugs he/she will select to work on. Sometimes the project on which the physician will be spending years of his/her life is of considerable medical interest, in other cases it is not. No matter what the case, the physician will be able to exercise only minimal control over what compounds he/she is working on at any given time. While it is possible for the clinical development of a new chemical entity to be poorly handled, it is not possible for the clinical researcher to add any characteristic that the particular chemical entity did not possess when it was synthesized.
In contrast to this, in the OTC area, the physician is actually in a position to greatly influence the choice of compounds on which he/she and the company will do research. He/she can even creatively discover new indications suitable for OTC therapy. The OTC physician typically enjoys major input into all decisions involved in the company's commitment to particular compounds and formulations. This is true for OTC switch and for new formulations of older products. The formulators in an OTC operation seek extensive input from their medical colleagues and the corporation looks to the physician for more than just straightforward opinions. Creativity is required and he/she has an opportunity to devise concepts that are actually developed by the company.
Since the development cycle of OTC drugs is much shorter than that of prescription compounds, the physician is often able to see an idea of his/her own brought to fruition in the form of an actual product. Typically, it requires only 3 years or less for the development of an OTC drug, as opposed to 7-10 years for a new chemical entity. The skillful use of medical knowledge and its creative application to new products can make all the difference in the medical and business success of an OTC company.
The extent to which the OTC physician is a key decision-maker is especially clear in dealing with the release to market of new formulations of drugs that have monograph status. Here the pharmaceutical physician makes direct judgments on the safety and marketability of products without the intervention of a regulatory agency. The US Food and Drug Administration has provided for the direct marketing of a wide variety of OTC drugs which it has pre-approved in the so-called 'monograph' system. The underlying concept of this system is that there are many drugs that have long been on the OTC market and for which abundant information already exists. Therefore, it would be redundant and wasteful for a new NDA to be submitted each time a new formulation of one of these compounds is to be brought to market. The FDA has provided a series of numerous monographs, each one of which deals with a particular narrow therapeutic area, ranging from acne and anthelminthics to hormones and weight control. The therapeutic area is discussed in some detail and specific requirements for well-established drugs in that area are set forth. As long as a new formulation remains within the exact requirements set forth in the monograph for type of drug, dosage, indication, and labeling statements, a compound may be formulated and marketed on the judgment of the company alone. No further pre-approval or examination of any application to the FDA is necessary. However, if the requirements set forth in the monograph for a particular compound are to be changed in any way by a different dosage, a new indication, or by changes in labeling, the formulation no longer is covered by the monograph and it is necessary to submit a full NDA. As long as the monograph requirements are strictly met, the physician in charge will make the final judgment on whether a new formulation is satisfactory for market. This system exists only in the USA and it provides for a striking amount of speed and flexibility in the OTC marketing of products.
However, it also places a very substantial amount of responsibility on the OTC physician. You can never appreciate the value of having a regulatory agency review your work and make the final decision to allow marketing until you don't have them and must take the responsibility yourself. This is particularly true with regard to the tolerability of new formulations. It is unlikely that major safety problems will arise with well-known drugs dosed at well-known levels for indications that are thoroughly understood. However, with topical drugs, where irritation and allergenicity are a problem, the judgment of suitability for market can be difficult. These drugs tend to be very dependent on the details of individual formulations and you want to be sure that you have enough information before you release them to market.
The need for specific clinical testing must be determined by the physician in each individual instance. A wide variety of situations may arise, varying from those in which no particular testing is required to those in which an extensive series of tests is needed before full confidence can be felt in a formulation. In short, the American monograph system provides unparalleled speed and flexibility of drug development for those compounds which come under it, but it requires particular vigilance on the part of the OTC physician. For all the delay and difficulty involved in obtaining approvals from FDA, it does have the major advantage that it provides a second source of learned judgment prior to the marketing of products. Even in the limited scope of monograph drugs, the physician can often find it necessary to use all his/her abilities to ensure that adequate testing is done and that careful judgments are made before individual formulations are allowed to reach the marketplace.
Because of the monograph system, one of the more striking features of OTC drug development is the speed with which new formulations may be moved from the conceptual stage to actual product realization. This contributes in a major way to the job satisfaction of the pharmaceutical physician, but it also creates a need to act with much more speed in advancing one's own portion of the development efforts. There is a need for the physician to participate in every phase of early planning of a development program. This is the only way to ensure that it is properly handled and can be quickly executed. Frequently, several companies will be moving forward with similar projects. Both commercial and personal success rely on being the first to market. Thus, the program must be planned for success on the first try. If major delays in research occur, the product will usually be so far behind competition in reaching the market that it will have little commercial value.
Several factors accelerate the entire process of research in the OTC area. Since it is much quicker and simpler for a product to remain within the monograph requirements, every effort is made to do so if it is possible. For research with monograph drugs, it is perhaps surprising to learn that an investigational new drug (IND) exemption is not always required prior to undertaking research. This is only logical, however, since for a monograph drug there is pre-approval from the FDA to actually launch the product into the market. It would not be sensible to require special pre-approval to perform human research via the IND system. This considerably speeds and simplifies the course of the research effort but again results in greater responsi bility for the OTC physician. The physician must ensure that the research undertaken will be complete and adequate for both safety and efficacy determination purposes and must make a solo judgment as to the safety of the research subjects involved, with no FDA oversight.
The details of the clinical research process are little different for OTC and prescription work. What changes most is the role of the pharmaceutical physician. This role is greater in scope and responsibility in the OTC area and everything must be done with greater speed.
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