Drug manufacturing is easy, not

Just ask Pfizer. This week Pfizer ran into a couple “issues” surrounding drug manufacturing. Ok, to be honest, Tris Pharm—a CMO—was issued the FDA warning letter, but it was for a Pfizer ADHD product (Quillivant XR) and Pfizer was named in the FDA letter. This is also not just an issue for Pfizer, but for patients. For example, 6.1% of American children are on ADHD medication. To add insult to injury, Quillivant was recently listed as a drug that is in short supply. Our advice, stock up on Quillivant. Also this week, the FDA released a Complete Response Letter (CRL) for the company’s proposed trastuzumab biosimilar. Using normal words; no soup for you as the FDA highlighted the need for additional technical information and does not relate to safety or clinical data submitted in the application. Hopefully next week will be better.