In light of the expanding global transparency trend, Mr. Oroho expresses the growing need for transparency consulting and reporting services, and discusses the keys to an effective global compliance program and the importance of an HCP-interaction risk management system.
Porzio was recently named the "notable small law firm" in the inaugural Life Science Law Firm Index, created by Breaking Media (publisher of MedCity News) and Lake Whillans, a distressed venture capital and litigation finance firm. The Index was created to identify the most active and relevant law firms for life science companies. Data was collected regarding firms' corporate, intellectual property and regulatory practice areas, in addition to their work with life science startup companies.
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By C. John DeSimone and Michael L. Rich
Most people know that the health care industry is awash in regulations, leading to ever-greater expansion of the field known broadly as "compliance." Few, however, know precisely when to recognize business activity that may trigger compliance issues.
For the past several years, Porzio Life Sciences, LLC (PorzioLS) has published an annual White Paper analyzing the evolution of the global transparency movement.
2016 represents a seminal moment in the global transparency movement for several reasons, the most significant being that this is the first year of reporting under the European Federation of Pharmaceutical Industries and Associations' ("EFPIA") "Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations" ("Disclosure Code"). Since EFPIA, which is comprised of thirty-three national member associations and forty-two full and affiliate corporate members, first adopted the Disclosure Code in 2013, there has been a great deal of speculation about what the reports would reveal and what the reaction would be from key stakeholders.
This White Paper not only examines the build-up to the first round of EFPIA disclosures that took place just a few months ago, but also the initial responses to the reported data from the press, advocacy groups, and, in some instances, governmental officials. It also reviews the debate between supporters and critics of EFPIA's approach, which is reflected by the title of this year's White Paper. As discussed more fully infra, the title references a statement from the Chief Executive of the British member of EFPIA, who believes that the first round of disclosures represent a milestone moment, whereas one critic characterized the voluntary industry initiative as a charade that "has all the thrust of a dead jellyfish."
Porzio Life Sciences, LLC ("PorzioLS"), a wholly-owned subsidiary of the law firm of Porzio, Bromberg & Newman, P.C. ("Porzio"), is dedicated to helping pharmaceutical, medical device and biotechnology organizations master the evolving regulatory environment.
In order to create a better understanding of the life sciences healthcare compliance environment and gain insight into how companies handle compliance challenges, PorzioLS has created the inaugural State of Life Sciences Healthcare Compliance Survey.
This survey is a compilation of the responses gathered from compliance professionals across a variety of life sciences companies, throughout all industry sectors and company sizes. The hope is that this data will serve as a useful benchmarking tool for life science compliance programs throughout the upcoming year.
The past two years have created a bit of uncertainty for life sciences promotional review professionals. With fewer enforcement letters, high-profile lawsuits, and a shift in marketing focus as a result of the Affordable Care Act, companies are struggling for a greater understanding of the Food and Drug Administration's ("FDA") enforcement objectives and some predictability to help with sales and marketing initiatives.
In 1998, FDA's Division of Drug Marketing, Advertising, and Communications ("DDMAC"), now the Office of Prescription Drug Promotion ("OPDP"), issued 158 enforcement letters. Over the years, the number of letters issued has decreased drastically. In stark contrast to the late 1990s, OPDP issued ten letters in 2014 and nine letters in 2015. Despite fewer letters, there is still much to be learned from the content of the communications and related FDA actions.
Also noteworthy, the past two years have demonstrated that OPDP enforcement is not reserved for larger pharmaceutical companies. In both years, a greater number of "small pharma" companies have received warning and untitled letters than "big pharma."
The public continues to be made aware of the financial relationships between industry and healthcare practitioners (HCPs) and the role that these transactions may play in creating bias and influencing prescribing choices. Current best practice guidelines, such as Good Publication Practice 3 (GPP3) and the International Committee for Medical Journal Editors (ICMJE) criteria for authorship support integrity and transparency in the publication of industry sponsored clinical trials’ data. A HCP industry specific transparency law, known as the US Federal Sunshine Act, was passed in 2010. Its main goal is to help reduce potential conflicts of interest that could harm clinical integrity and patient care and increase healthcare costs. Other countries have followed suit.
Unfortunately, the global transparency report ing requirements have little detail about non-monetary support for medical writing and editing, and whether or not it constitutes a transfer of value (TOV) to HCPs. Despite this lack of clarity, medical writers should be aware of the current landscape and should be able to discuss the various aspects of the global transparency requirements.
Porzio Life Sciences ("PorzioLS") has been a leading resource for the life sciences industry for over 11 years. The 2014 Year-End Report was the first annual PorzioLS accounting of the headlines and emerging trends of the prior year. Continuing in this vein is the 2015 Year-End Report: Navigating the Regulatory Landscape.
Porzio is pleased to announce that Porzio-supported legislation was signed into law by New Jersey Governor Chris Christie. As a result, product approval from the U.S. Food and Drug Administration (FDA) is no longer a condition for a pharmaceutical company to receive registration approval by the State Department of Health. As registration in a company's home state is one of the necessary first steps in the process for a new drug to be brought to market, the requirement imposed by the State Department of Health was particularly burdensome on companies based in New Jersey. This legislation further requires the Department of Health to review registration statements and reply to the registrant within 30 days of receipt.
Porzio Governmental Affairs, LLC and Porzio Life Sciences, LLC initiated the introduction of this legislation by Senators Fred H. Madden, Jr. (D-Gloucester) and Steven V. Oroho (R-Sussex) and Assemblyman Tim Eustace (D-Bergen). Designated as S2024/A3793, the legislation passed both houses of the legislature unanimously before heading to the Governor's desk.
Frank Fazio, Porzio principal and Porzio Life Sciences Vice President of Distribution and Licensing Services, testified in support of S2024 before the New Jersey Senate Health, Human Services and Senior Citizens Committee, and before the Assembly Health and Senior Services Committee in support of A3793. Prior to the introduction of the legislation, he brought the issue before the Red Tape Review Commission in September of 2015, outlining the obstacles being faced by biotech companies with the existing registration process. Stated Senator Madden, "This legislation will allow New Jersey biopharmaceuticals the same advantage of registering their products while they wait for FDA approval, as is the policy in many of our neighboring states."
Lobbying efforts were spearheaded by Porzio Government Affairs Executive Vice President Lynn Nowak. She was recently featured on Senate Majority Leader Weinberg's annual list of the most powerful and influential women in New Jersey civic affairs. Ms. Nowak has represented the interests of a wide variety of clients before the legislature and executive branch for over two decades.
Porzio is grateful to Senators Madden and Oroho and Assemblyman Eustace for their leadership on this issue. Stated Assemblyman Eustace, “New Jersey is the medicine box of the world and we must make every effort to allow for new drugs to get to the marketplace quicker and cheaper. Working together we can find ways to deliver needed therapies to patients at lower costs.”
According to Senator Oroho, “This law will reduce the time it takes for drug companies to set up shop in New Jersey… If we can make government more efficient, we can make the state better for business and cheaper for residents. This law is another step toward that goal, but we must continue our efforts in order to ensure our economic prosperity."
Porzio is proud to support our clients' goals and to be able to enact significant changes that will aid New Jersey businesses and industry going forward.
The Dietary Supplement Health and Education Act of 1994 (DSHEA) made clear that supplements are not held to the same substantiation requirements as drugs. But despite DSHEA and two decades of guidance from the FDA and the Federal Trade Commission (FTC), the federal government has resorted to the use of costly litigation as a means of forcing the industry to obtain “gold standard” evidence.
The Natural Products Association (NPA) believes that the government’s litigation-driven strategy is contrary to both law and consumer welfare. Porzio principals Kevin M. Bell and Richard J. Oparil represented NPA in filing “friend of the court” amicus briefs in the government’s latest case against Bayer’s probiotic product, asking the Court to reject a broad requirement that structure/function claims for human dietary supplements may only be substantiated using expensive and burdensome RCTs. A contrary result would financially devastate the dietary supplement industry and cause consumers to lose access to supplements that they find beneficial and want to use.
To read the full NPA NOW article, please click here.