The practice of compounding does, however, raise certain quality assurance issues such as the reliability and consistency of drug sources, and the lack of testing and regulation of the drug. The validity and safety of drug compounding was called into question by Bob Consalvo, Schering-Plough's manager of media relations. As he stated, the quality of Rebetol may vary from supplier to supplier, and because Fisher's would not reveal their source, there is no way to assure consumers about the safety and bioequivalence of the drug. Additionally, Consalvo noted that Fisher's may not be properly labeling the drug with all of the appropriate data, side effects profile, and warnings noted on the FDA-approved package insert given out with Rebetron. Pointing out that Rebetol is only FDA-approved in combination with Intron A, Consalvo questioned the ethics and legality of dispensing it separately.
More information is needed via clinical trials to test the safety and efficacy of such combinations.
By bundling drugs and not making Rebetol readily available for clinical trials, Schering-Plough is seen by activists as interfering with this process. This statement raises an issue about the relationships between competing pharmaceutical companies. On one hand, it is understandable that a for-profit company would wish to protect their assets and take pride in products for which they worked so hard to gain FDA approval. The company would not necessarily want to help a competing company develop a drug that works better with their product. On the other hand, the well-being of the patient may end up hanging in the balance.