Deadline Looms for Pharmaceutical Manufacturers and Distributors to Comply with New Expanded Access Program Reporting Requirements

Certain pharmaceutical manufacturers and distributors of an investigational drug under an investigational new drug (IND) application must make their policies for evaluating and responding to requests under an expanded access program “public and readily available” by the end of this week pursuant to section 3032 of the 21st Century Cures Act (Cures). Cures, which became effective on December 13, 2016, provided a deadline for making the policies available on the later of: (i) 60 days after the enactment of Cures, or (ii) the first initiation of a phase 2 or phase 3 study with respect to the investigational drug. Therefore, the 60-day deadline expires on Saturday, February 11, 2017, for those manufacturers and distributors who are already conducting a phase 2 or 3 study under an IND. Continue reading

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Filed under Clinical Trials, Compliance, FDA

OIG Issues Final Rule Re: Exclusion Authority

The Final Rule related to the Health and Human Services Office of Inspector General’s (OIG) exclusion authority pursuant to the Social Security Act (the Act), as amended by the Affordable Care Act (ACA) and the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), was released last week. The Proposed Rule was issued previously by the OIG in May 2014. The effective date of the Final Rule is February 13, 2017.

Noteworthy changes made by the Final Rule include the following key items:

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Filed under Fraud and Abuse, Government Enforcement, OIG Guidance

FDA Issues Discussion Paper on Laboratory Developed Tests

The U.S. Food and Drug Administration (FDA) issued today a Discussion Paper on Laboratory Tests (LDTs). The Discussion Paper follows draft guidance issued by the FDA in 2014 (2014 Draft Guidance) and a stakeholder workshop held in 2015 regarding the oversight of LDTs. The Discussion Paper does not represent final guidance. Rather, the Discussion Paper is the FDA’s “synthesis of all feedback” received, which the FDA hopes will “advance public discussion on future LDT oversight.” The Discussion Paper is not enforceable.

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Filed under FDA, Laboratories

Medicare Part B Demo Declared Dead

On Thursday, the Center for Medicare & Medicaid Services (CMS) announced that it would not move forward with its controversial Medicare Part B Payment Model  (Part B Demo).  The Part B Demo had come under heavy fire from industry groups, some patient organizations, providers and a bipartisan collection of policymakers in Congress. Continue reading

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Filed under Coverage and Reimbursement, Government Pricing, Health Care, Medicare, Uncategorized

21st Century Cures Clears Senate, President Expected to Sign into Law but Some Issues Remain

Today, the Senate voted overwhelmingly – 94-5 – to pass sweeping medical innovation legislation clearing the way for President Obama to sign it into law when it reaches his desk later this week. The 21st Century Cures Act, (Cures), a rare bipartisan major piece of healthcare legislation, provides $6.3 billion for research, streamlined approvals for drugs and devices as well as funding to improve the Food and Drug Administration’s (FDA)  ability to hire top quality scientific talent by increasing pay and improving the hiring process.  The House of Representatives recently passed Cures by a similarly wide bipartisan margin of 392-26.  The Senate vote marks a milestone victory for Cures champions including outgoing Energy and Commerce Committee Chairman Fred Upton (R-MI), Representative Diana DeGette (D-CO) and Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander (R-TN). Continue reading

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Filed under FDA, Health Care, Health Reform, Technology, Uncategorized

FDA hits the brakes on LDT draft guidance

Last week the Food and Drug Administration (FDA) decided to delay finalizing draft guidance for Laboratory Developed Tests (LDT).  First issued in July of 2014, the draft guidance would give FDA regulatory oversight of LDTs.  This guidance marked a significant shift in the regulation of LDT as FDA has chosen not to exercise regulatory oversight or enforcement over LDTs.  Continue reading

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Filed under FDA Draft Guidance, Health Care, Laboratories, Uncategorized

Pharmaceutical Reps Now Required to be Licensed in the City of Chicago; Includes Code of Ethics & Potential Transparency Reporting

Earlier this week, the Chicago City Council joined other government agencies in imposing licensure and marketing requirements on pharmaceutical representatives when it unanimously approved licensing requirements for pharmaceutical representatives in the City of Chicago. Individuals who conduct business in the City of Chicago as a pharmaceutical representative for 15 or more days per year must obtain a license, which includes completing an educational course determined by the Commissioner of Public Health (Commissioner), submitting a registration form to the Department, and paying a $750 licensure fee. Renewal applicants will be required to complete at least 5 hours of continuing education in the areas of ethics, pharmacology, laws and regulations applicable to pharmaceutical marketing, and other areas that the Commissioner may designate by rule. Training courses may not be provided by the pharmaceutical representative’s employer. The ordinance takes effect on July 1, 2017.

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Filed under Industry Codes, Sales & Marketing, State Marketing & Disclosure Laws