Latest Articles

Fresh off his noticeably smooth confirmation, the new Commissioner of Food and Drugs, Dr. Scott Gottlieb, appeared before Congress last Thursday and unveiled his strategic initiatives and priorities for the Trump Food and Drug Administration (“FDA”).  These run the gamut from improving regulatory science and policies to streamlining clinical trials to spurring innovation on behalf of patients.  Two initiatives, in particular, merit closer attention and discussion: combating opioid abuse and addressing drug price increases through…
Price increases threatening the availability of EpiPen® and EpiPen Jr® Auto-Injectors (“EpiPen”) have touched off the latest firestorm over drug pricing. Lost amid the public outcry, however, is a thorny regulatory issue: EpiPen’s classification as a generic drug for purposes of the Medicaid Drug Rebate Program (“MDRP”).  Resolution of the classification issue carries significant risk for segments of the drug industry.…
Although the 12-year exclusivity period for original biologic products was a heavily negotiated provision of the Biologics Price Competition and Innovation Act (BPCIA), increased spending on biologic drugs has led to calls to shorten that exclusivity period to expedite biosimilar market entry. Most recently, on June 23, 2016, Illinois Congresswoman Jan Schakowsky and Senators John McCain (R-AZ) and Sherrod Brown (D-OH) introduced the “Price Relief, Innovation, and Competition for Essential Drugs” (PRICED) Act in the U.S. House of Representatives…
Although the 12-year exclusivity period for original biologic products was a heavily negotiated provision of the Biologics Price Competition and Innovation Act (BPCIA), increased spending on biologic drugs has led to calls to shorten that exclusivity period to expedite biosimilar market entry. Most recently, on June 23, 2016, Illinois Congresswoman Jan Schakowsky and Senators John McCain (R-AZ) and Sherrod Brown (D-OH) introduced the “Price Relief, Innovation, and Competition for Essential Drugs” (PRICED) Act in the U.S. House of Representatives…
Although the 12-year exclusivity period for original biologic products was a heavily negotiated provision of the Biologics Price Competition and Innovation Act (BPCIA), increased spending on biologic drugs has led to calls to shorten that exclusivity period to expedite biosimilar market entry. Most recently, on June 23, 2016, Illinois Congresswoman Jan Schakowsky and Senators John McCain (R-AZ) and Sherrod Brown (D-OH) introduced the “Price Relief, Innovation, and Competition for Essential Drugs” (PRICED) Act in the U.S. House of Representatives…
Although the 12-year exclusivity period for original biologic products was a heavily negotiated provision of the Biologics Price Competition and Innovation Act (BPCIA), increased spending on biologic drugs has led to calls to shorten that exclusivity period to expedite biosimilar market entry. Most recently, on June 23, 2016, Illinois Congresswoman Jan Schakowsky and Senators John McCain (R-AZ) and Sherrod Brown (D-OH) introduced the “Price Relief, Innovation, and Competition for Essential Drugs” (PRICED) Act in the U.S. House of Representatives…
Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of affordable generic drugs” and biosimilar products. The bill, entitled the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016, S. 3056, would punish the strategic refusal of “innovator” companies to (1) share drug samples needed for generic and biosimilar regulatory testing and…
Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of affordable generic drugs” and biosimilar products. The bill, entitled the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016, S. 3056, would punish the strategic refusal of “innovator” companies to (1) share drug samples needed for generic and biosimilar regulatory testing and…
Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of affordable generic drugs” and biosimilar products. The bill, entitled the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016, S. 3056, would punish the strategic refusal of “innovator” companies to (1) share drug samples needed for generic and biosimilar regulatory testing and…