Friday, January 31, 2014

FDA Law Blog January 30, 2014 Speech by High-Level DOJ Official Claims Shared Interests of Prosecutors and Regulated Industry

By JP Ellison
In a speech on January 29th at the CBI Pharmaceutical Compliance Congress that DOJ posted on its own website, U.S. Department of Justice Assistant Attorney General Stuart Delery set forth his views of the three ways that the government’s enforcement interests align with industry’s interests.  While the speech didn’t break any new ground, it serves as a reminder that pharmaceutical enforcement cases remain a DOJ priority and suggests that recent enforcement trends will continue.
AAG Delery Claimed that DOJ and industry shared the following:
  1.  “[A] common interest in promoting ethical corporate culture instead of maintaining a compliance program in name only;”
  2. “Transparency about the conduct [the government] investigate[s];” and
  3. “[A] common interest in ensuring that corporate compliance is not only the right thing to do but also a winning business strategy.”
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Thursday, January 30, 2014

New York issues summary suspension against Rockwell Compounding Associates Inc.

. SUMMARY SUSPENSIONS
Pharmacy
Steven J. Cosentino; Pharmacist; Rye, NY 10580; Lic. No. 031570; Cal. No. 27162; Application for summary suspension granted.
Rockwell Compounding Associates, Inc.; Pharmacy; 350 Theodore Fremd Avenue, Rye, NY 10580; Reg. No. 026458; Cal. No. 27163; Application for summary suspension granted.

quoted from here

Regulatory Reconnaissance: Does CDER Need New Leadership? (30 January 2014)

Regulatory Reconnaissance: Does CDER Need New Leadership? (30 January 2014)

New England Compounding Pharmacy, Inc. Bankruptcy New Filing Alert: Motion For Relief From The Automatic Stay

 

On January 29, 2014, a motion for relief from the automatic stay was filed in the bankruptcy case of New England Compounding Pharmacy, Inc.  and its affiliates. The filing was assigned docket number 663 and is described on the court’s official docket as follows:
Motion filed by Plaintiffs Irene and Joseph Phillips, Norma Montague, Ronald and Tammy Driscoll for Relief from Stay Re: Fee Amount $176, Objections due by 02/12/2014. (Attachments: # (1) Exhibit Memorandum in Support of Motion for Limited Relief From Stay on Behalf of Movants) (Gonzalez, Ervin)

quoted here

Look at what one of DOJ and US Attorney's Offices Top Priorities is for 2014!!

Enforcement Priorities looking ahead to 2014
- See more at: http://www.policymed.com/2014/01/pharmaceutical-and-device-healthcare-fraud-enforcement-perspectives-for-2014.html#sthash.qc7itemB.dpuf