Pepcid Ac: Racing to the Otc MarketEssay Preview: Pepcid Ac: Racing to the Otc MarketReport this essayJohnson & Johnson/Merck Consumer Pharmaceuticals Co. (JJM) was faced with a major strategic decision. There was a major rush to the over-the-counter (OTC) medication market. JJM developed a lower dose version of its prescription Pepcid traditionally used to treat ulcers and gastroesophageal reflux disease (GERD). The lower-dose version, Pepcid AC, was the third OTC medication developed. SmithKline was the first to the market with Tagamet in 1977 and Glaxo followed six years later with Zantac. Three years later, in 1986, Merck developed Pepcid and Eli-Lilly came out with Axid. These four drugs accounted for 95% of the prescription market for ulcer medications.
The FDA is on board that the drug is safe, effective, and has no safety issues whatsoever. FDA has spent several years considering the safety, effectiveness, and safety of various drugs and that they want it to be FDA-approved:
• Prescription drugs are the most reliable medicine for every patient.
• The FDA does not allow any drug to be labeled as an alternative to an FDA prescription that would otherwise be the product of two different manufacturers of the same drug.
If FDA decides to deny a drug’s approval under Part B of §17A of the Controlled Substances Act (CSA) to a drug for medical purposes, the FDA says: “This Section does not apply in this action to drugs or substances that the FDA believes, based on its own assessment, are not required to be included within the prescribed clinical care by the Federal, State, or local health care system.”
• The government, in its efforts to limit abuse by the pharmaceutical industry, has not found significant differences, when it comes to prescribing in drug trials, from a recent rule from the Federal Trade Commission (FTC) that concluded that the FDA might not require a drug-company to do so.
To put this point in perspective, the Federal Trade Commission ruled that the FDA could not impose a mandatory or mandatory compliance program where it found that a drug was not medically necessary, that it did not have a proven track record of safety, and that it has never undertaken an OTC regimen in clinical practice.
So, for the FDA in this action, the first thing it will be asking the government is: does the FDA have a clear policy on its own prescribing of drugs if there’s a good reason for it to? The FDA does not. It does not want to impose a burden on anyone that could be placed on it to give an FDA approval that might put it on the right path to success. This action may be a first in Congress and it has some implications that include the safety issue, but, at the end of the day, the FDA has to decide what’s best for those patients. FDA does have control over drug approvals. It can make that choice for the American people. It may also be a way for the FDA to push back. As the agency has to decide what is best for each individual patient and the patients they care for, and if FDA’s decision should take too long, it should look to other options in the future to ensure it’s a step-by-step process for people with conditions, like me. These decisions will be carefully considered in making the decisions that go along it. That’s why the FDA has to ensure that patients do not get put on the FDA’s path to failure.
Read the FDA Action Plan
Federal Law
Federal Law §1581
Federal Food, Drug
The FDA is on board that the drug is safe, effective, and has no safety issues whatsoever. FDA has spent several years considering the safety, effectiveness, and safety of various drugs and that they want it to be FDA-approved:
• Prescription drugs are the most reliable medicine for every patient.
• The FDA does not allow any drug to be labeled as an alternative to an FDA prescription that would otherwise be the product of two different manufacturers of the same drug.
If FDA decides to deny a drug’s approval under Part B of §17A of the Controlled Substances Act (CSA) to a drug for medical purposes, the FDA says: “This Section does not apply in this action to drugs or substances that the FDA believes, based on its own assessment, are not required to be included within the prescribed clinical care by the Federal, State, or local health care system.”
• The government, in its efforts to limit abuse by the pharmaceutical industry, has not found significant differences, when it comes to prescribing in drug trials, from a recent rule from the Federal Trade Commission (FTC) that concluded that the FDA might not require a drug-company to do so.
To put this point in perspective, the Federal Trade Commission ruled that the FDA could not impose a mandatory or mandatory compliance program where it found that a drug was not medically necessary, that it did not have a proven track record of safety, and that it has never undertaken an OTC regimen in clinical practice.
So, for the FDA in this action, the first thing it will be asking the government is: does the FDA have a clear policy on its own prescribing of drugs if there’s a good reason for it to? The FDA does not. It does not want to impose a burden on anyone that could be placed on it to give an FDA approval that might put it on the right path to success. This action may be a first in Congress and it has some implications that include the safety issue, but, at the end of the day, the FDA has to decide what’s best for those patients. FDA does have control over drug approvals. It can make that choice for the American people. It may also be a way for the FDA to push back. As the agency has to decide what is best for each individual patient and the patients they care for, and if FDA’s decision should take too long, it should look to other options in the future to ensure it’s a step-by-step process for people with conditions, like me. These decisions will be carefully considered in making the decisions that go along it. That’s why the FDA has to ensure that patients do not get put on the FDA’s path to failure.
Read the FDA Action Plan
Federal Law
Federal Law §1581
Federal Food, Drug
The strategic decision JJM was placed in was due to a decision made by the advisors to the FDA. All drugs had to go through an extensive review process with the FDA (approximately 8 years for the initial drug, however, a bit shorter when moving the established drug to OTC). JJM initially developed their strategy with rolling out Pepcid AC to the FDA as a “preventative” drug as well as for “treatment,” accepting that Tagamet would likely be the first entrant. SmithKline Beechams discussions with the FDA began in 1985 well before JJM, however, they presented their product as only for treatment purposes. As a result, Pepcid AC attempted to capitalize on that and tried to gain entry as the second-mover and requesting approval as a preventative medication as well.
However, both SmithKline and JJM were directed to go back to the market and conduct more research by the FDA advisors within one year of each other. Now, Pepcid AC had to determine if it wanted to capitalize on being the first entrant. In order to do so, JJM would have to eliminate its “preventative” campaign as this was unprecedented and would require a substantial amount of capital to research, knowing that the FDA typically does not like preventative medications because they could potentially mask other, serious symptoms.
After conducting a number of additional studies, including consumer usage behavior, concept testing (Bases I and II analysis), focus groups, and researching the roles of physicians and pharmacists, JJM concluded that while the treatment concept outperformed prevention in the BASES analyses, the results in the remaining studies favored both prevention and treatment. Additionally, JJM took the position that prevention could provide new benefits and opportunities for new usage occasions that would in turn drive growth.
Consequently, based on the research conducted, I believe that if JJM eliminated the prevention concept and achieved the first-mover advantage, that advantage would quickly dwindle as the rest of the products were approved, entered the market, patent protection expired and generic products increased (ex. Glaxo quickly pushed SmithKline aside with a more convenient dosage despite a higher price). JJM could continue to maintain its