3 TIPS YOU NEED To KNOW:BUT MAY SCARE YOU

DARSHAN KULKARNI

PHARM.D, MS, ESQ

@FDALAWYERS

THE KULKARNI LAW FIRM

Agenda

• Bad News: • Sales Rep/ Speaker criminally prosecuted• Banned from working in pharma/ healthcare• You arn't paranoid: They are ALL looking at you.

• Good News:o Can be prevented but will hurt

• Updateso Social Mediao IMS o Citizens Petition

Bad NewsBad News

US v. Coronia

• Facts

• Impact

• Company

• Sales Rep

• Speaker

Purdue Fredrick

What happened

Result:

Company

Exclusions

Bad Ad Program

• What is it? • Is it too soon to determine impact?

AANN O OUNCEUNCE O OFF PPREVENTIONREVENTION I ISS

BBETTERETTER T THANHAN AA PPOUNDOUND O OFF C CUREURE

Avoiding Problems

• Prospective Compliance • Training

 • Auditing

What’s Next?What’s Next?

Upcoming Changes

• Social Media policies • Sorrell v. IMS (Sup Ct Decision) 

 • Citizens Petition

TAKE AWAY

• Prosecutions do not only happen after approval. • Your company may pay fines• Your speakers may go to jail • You may pay fines • You may never work in healthcare/ pharma again• You may go to jail• You are not paranoid: The walls have eyes & ears

 

QUESTIONS

Darshan KulkarniPharm.D, MS, Esq W: http://www.conformlaw.comT: 215-703-7842Twitter: @FDALawyers Sign Up for Updates