Newsletter - August 13, 2015
Courts Goes Against FDA to Allow Off-Label Promotion… Again
Off-label promotion is an enigma; it is legal if the doctors do it or if the patients do it by drawing interpretations based on their experience or reading journal articles but it is illegal if a drug company talks about the same information. More than one in five prescriptions (21%) written in the US are for off-label purposes. For some drugs such as antidepressants and pain medication, more than 90% of prescriptions written for pediatric and adolescent populations are for off-label purposes. At the same time, FDA has successfully litigated against companies for making off-label promotional claims leading to files as high as to a billion dollars and one and a half billion dollars. More...
GMP Issues for 3D Printed Pills Resolved But Is It Really a Big Deal?
On 31st July 2015, FDA approved the World’s first 3D printed pill and it was widely celebrated as a major milestone and, in my ways it is, but for the reasons one may think. The approval is for a new formulation of a well-established epilepsy drug, levetiracetam, called Spritam®. With more than 80 generic drugs containing levetiracetam in the US market, this new drug approved under the 505(b)(2) regulatory pathway will likely not be a big money maker for the developer, Aprecia Pharmaceuticals. The drug is not as customizable as one would think reading the pundits; it is approved at 4 fixed doses not different from the other generic versions. More...
The Promise of Bacteriophage Therapy Rekindled but Hurdles Remain
Antibiotic resistance is a mounting public health concern with the CDC estimating the annual added cost of treating antibiotic-resistant infections at $20 billion in the US alone. The CDC also estimates that 50-70% of hospital-acquired infections are now resistant to first-line antibiotics. Given the dearth of new classes of antibiotics, drug companies are looking at non-traditional approaches such as bacteriophage (phage) therapy to compete in this market. Phages are naturally occurring viruses that consume bacteria by hijacking their metabolic processes to replicate before rupturing the host cells to release new viruses. Once all bacteria have been destroyed, the phage is cleared harmlessly by the body. More...
Courts Goes Against FDA to Allow Off-Label Promotion… Again
Off-label promotion is an enigma; it is legal if the doctors do it or if the patients do it by drawing interpretations based on their experience or reading journal articles but it is illegal if a drug company talks about the same information. More than one in five prescriptions (21%) written in the US are for off-label purposes. For some drugs such as antidepressants and pain medication, more than 90% of prescriptions written for pediatric and adolescent populations are for off-label purposes. At the same time, FDA has successfully litigated against companies for making off-label promotional claims leading to files as high as to a billion dollars and one and a half billion dollars. More...
GMP Issues for 3D Printed Pills Resolved But Is It Really a Big Deal?
On 31st July 2015, FDA approved the World’s first 3D printed pill and it was widely celebrated as a major milestone and, in my ways it is, but for the reasons one may think. The approval is for a new formulation of a well-established epilepsy drug, levetiracetam, called Spritam®. With more than 80 generic drugs containing levetiracetam in the US market, this new drug approved under the 505(b)(2) regulatory pathway will likely not be a big money maker for the developer, Aprecia Pharmaceuticals. The drug is not as customizable as one would think reading the pundits; it is approved at 4 fixed doses not different from the other generic versions. More...
The Promise of Bacteriophage Therapy Rekindled but Hurdles Remain
Antibiotic resistance is a mounting public health concern with the CDC estimating the annual added cost of treating antibiotic-resistant infections at $20 billion in the US alone. The CDC also estimates that 50-70% of hospital-acquired infections are now resistant to first-line antibiotics. Given the dearth of new classes of antibiotics, drug companies are looking at non-traditional approaches such as bacteriophage (phage) therapy to compete in this market. Phages are naturally occurring viruses that consume bacteria by hijacking their metabolic processes to replicate before rupturing the host cells to release new viruses. Once all bacteria have been destroyed, the phage is cleared harmlessly by the body. More...