Dept. of Justice speaks out against ‘pay-for-delay’ deals
WASHINGTON The Department of Justice has come out against so-called “pay-for-delay” deals between branded and generic drug companies, according to published reports.
The DOJ’s antitrust division asserted in a court filing that patent settlements between branded and generic drug companies in which branded drug manufacturers pay generic manufacturers not to challenge their patents should be considered illegal, according to The Wall Street Journal. The DOJ further asserted the deals should be considered legal only when it can be demonstrated that they don’t stifle competition.
Such settlements have attracted controversy, with the Federal Trade Commission and now the DOJ saying they prevent competition, while the generic drug industry asserts that the settlements ensure generic drugs make it to market in a timely fashion, thus promoting competition. Generic drug companies often use the settlements to persuade branded drug companies not to release “authorized generics” – branded drugs sold under their generic names – during the 180-day period when a generics company has the exclusive right to market the generic version of a drug.
CVS Caremark renews distribution agreements
SAN FRANCISCO McKesson has renewed its distribution agreement to supply CVS Caremark with branded and generic drugs, the company announced on Monday.
“CVS Caremark’s decision to renew its agreement with McKesson is reflective of the trusted relationship between our two companies and the value McKesson has delivered to CVS Caremark over the years,” stated Paul Julian, EVP, group president for McKesson. “McKesson’s comprehensive supply chain solutions help CVS Caremark ensure the highest levels of product availability and product integrity, empowering CVS Caremark to provide outstanding pharmaceutical care and further strengthen its competitive position.”
In related news, the retail giant also announced that it has renewed its distribution agreement with Cardinal Health. CVS Caremark said Cardinal Health will supply pharmaceuticals to its national network of retail pharmacies through mid-2013.
“We have a long-standing partnership with CVS Caremark, and we are proud to continue this important relationship,” said George Barrett, vice chairman of Cardinal Health and CEO of the Healthcare Supply Chain Services segment. “The footprint of the agreement is expected to be fundamentally the same as our existing relationship.”
Additional terms of the agreement were not disclosed.
FDA rejects application of pain-relief drug
PALATINE, Ill. The Food and Drug Administration has rejected an approval application for a pain-relief drug.
Acura Pharmaceuticals and King Pharmaceuticals announced that the FDA had issued a letter turning down their application for Acurox (oxycodone HC1, USP and niacin, USP), an immediate-release drug designed to relieve moderate to severe pain.
The companies said the letter expressed concerns about the potential abuse deterrent benefits of the drug. One of the drug’s ingredients, oxycodone, is a opiate-derived controlled substance popular with drug abusers.