Newsletter - October 8, 2015
Pharma Product Hopping and Product Evergreening in the Limelight Again
The “war” against high drug prices heats up even more this week when in a court filing Federal Trade Commission (FTC) strongly criticized practices used by the pharma companies to keep the drug prices high using questionable business and regulatory practices against generics. Pharma companies use two processes to increase the competitive advantage of their products over generics; filing new patents for seemingly minor updates to a given product, called Product Evergreening, and creating new products similar to the original product and then practically forcing patients to switch to the new version, called Product Hopping. Read More..
Updates to GCP and US Government Policies for Clinical Trial Patients
Much needed major updates to the GCP guidance and the Common Rule were proposed by the FDA and DHHS recently. These changes are being proposed to modernize the regulatory requirements to match the current practices for clinical trials. In one of the most comprehensive updates to the human subject protection rules that apply to clinical trials funded by the US government in almost 25 years, 16 agencies of the US government jointly published notice to amend the Federal Policy for Protection of Human Subjects. The law was created in early 1974 and final adopted in 1991 to create a uniform body of regulations across all Federal departments and agencies, and called the “Common Rule”. Read More..
Lack of GMP Training is Expensive: Lessons from Compounding Pharmacies
Since the passage of the Compounding Quality Act in late 2013, compounding pharmacies have had a rough experience trying to comply with tough GMP rules. Of the almost 60 compounding pharmacies that voluntarily registered with the FDA, almost 50 have gone through FDA’s audit for GMP compliance and all but one were found to be in significant GMP violations and received FDA 483s. Of the 50 pharmacies audited, 12 received Warning Letters, and three were subject to product recalls. In addition to the pharmacies registered with the FDA, audits were conducted at numerous other compounding pharmacies and 483s issued. Read More..
Pharma Product Hopping and Product Evergreening in the Limelight Again
The “war” against high drug prices heats up even more this week when in a court filing Federal Trade Commission (FTC) strongly criticized practices used by the pharma companies to keep the drug prices high using questionable business and regulatory practices against generics. Pharma companies use two processes to increase the competitive advantage of their products over generics; filing new patents for seemingly minor updates to a given product, called Product Evergreening, and creating new products similar to the original product and then practically forcing patients to switch to the new version, called Product Hopping. Read More..
Updates to GCP and US Government Policies for Clinical Trial Patients
Much needed major updates to the GCP guidance and the Common Rule were proposed by the FDA and DHHS recently. These changes are being proposed to modernize the regulatory requirements to match the current practices for clinical trials. In one of the most comprehensive updates to the human subject protection rules that apply to clinical trials funded by the US government in almost 25 years, 16 agencies of the US government jointly published notice to amend the Federal Policy for Protection of Human Subjects. The law was created in early 1974 and final adopted in 1991 to create a uniform body of regulations across all Federal departments and agencies, and called the “Common Rule”. Read More..
Lack of GMP Training is Expensive: Lessons from Compounding Pharmacies
Since the passage of the Compounding Quality Act in late 2013, compounding pharmacies have had a rough experience trying to comply with tough GMP rules. Of the almost 60 compounding pharmacies that voluntarily registered with the FDA, almost 50 have gone through FDA’s audit for GMP compliance and all but one were found to be in significant GMP violations and received FDA 483s. Of the 50 pharmacies audited, 12 received Warning Letters, and three were subject to product recalls. In addition to the pharmacies registered with the FDA, audits were conducted at numerous other compounding pharmacies and 483s issued. Read More..
