On June 6, 2019, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a report that found that, among a sample U.S. hospitals that obtained non-patient-specific (NPS) compounded drugs...more
On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral...more
6/16/2017
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Declaratory Judgments ,
FDA Approval ,
Generic Drugs ,
IP License ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Pharmaceutical Patents ,
Pharmacies ,
Preemption ,
Preliminary Injunctions ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS ,
State Law Claims
Last week FDA published a notice of public meeting and a request for comments regarding certain aspects of the Drug Supply Chain Security Act (DSCSA). The meeting will take place on October 14, 2016 at the Agency’s campus in...more
Last month, FDA released three draft guidance documents that are expected to have significant implications for traditional pharmacy-based compounding and the distribution of those drug products....more
On October 6th, California’s governor signed Senate Bill 671, which permits pharmacists to substitute an interchangeable biological product for a prescribed biological product. The California legislature had attempted to pass...more
10/17/2015
/ Biologics ,
Biosimilars ,
Comment Period ,
Generic Drugs ,
Governor Brown ,
New Legislation ,
Notice Requirements ,
Pharmacies ,
Pharmacist ,
Prescription Drugs ,
Proposed Regulation
Last week FDA took another important step in implementing the complex and interlocking provisions of the Drug Supply Chain Security Act (DSCSA). We have previously discussed the new Federal drug traceability requirements and...more
10/12/2015
/ Covered Entities ,
Databases ,
Distributors ,
DSCSA ,
Due Diligence ,
Food and Drug Administration (FDA) ,
Licenses ,
Pharmaceutical Distribution ,
Pharmacies ,
Prescription Drugs ,
Supply Chain ,
Third-Party Service Provider ,
Wholesale
As we’ve previously discussed, states have begun to actively regulate the substitution of interchangeable biosimilars before any FDA-approved biosimilar has even hit the market. State biosimilar legislation passed to date...more
On June 30, 2015, a mere day before the product tracing deadline for dispensers was to go into effect, FDA published a compliance policy guidance that delays enforcement of the applicable product tracing requirements until...more
Beginning July 1, 2015, most pharmacies in the U.S. will be required to have systems in place to receive transaction information regarding the prescription drugs they purchase from suppliers. The requirement stems from a...more
On the heels of its approval of the first biosimilar product in March, FDA has just released final versions of three key biosimilar guidance documents under the Biologics Price Competition and Innovation Act (BPCIA). The...more