John J. Gilluly III
Austin Managing Partner
And Head, Texas
WELCOME TO THIS ISSUE
Welcome to the summer issue of News and Insights. In this issue, I’m proud to highlight Becca McKnight, who was recently selected by The Food and Drug Law Institute (FDLI) to serve on its Medical Devices Committee. Becca shares more about her FDA practice and approach to client service below.
We also feature a brief overview of the FDA’s new draft guidance on Quality Agreements for drug manufacturing companies, a significant issuance that addresses methods of defining, establishing and documenting the responsibilities of each party involved in the contract manufacturing of drugs.
This issue also highlights the Uniform Trade Secrets Act recently adopted in Texas and taking effect on September 1, 2013, as well as Texas HB 500 which provides for certain changes to the Texas franchise provisions.
On behalf of the DLA Piper team, I hope this latest issue of News and Insights is useful for you.
John J. Gilluly III
MEET BECCA MCKNIGHT
Rebecca Jones McKnight
Photo provided by the Food
and Drug Law Institute
My “algorithm on the window” moment may not have launched a juggernaut social network, but it launched a career in FDA law that I continue to find challenging and satisfying.
It was the summer of 2002, and I was making my first foray into the complex web of the Food, Drug & Cosmetic Act and FDA regulations. As a summer associate, I was asked to analyze a question about the development, approval and potential marketing protection of pharmaceuticals for pediatric patients.
My tool? A whiteboard, where I hashed out a flow chart tracking the interrelating requirements, scattered and cross-referenced across the US Code and the Code of Federal Regulations.
The deliverable? A ten-minute conversation providing the bottom line.
This formative experience has colored my approach to advising clients ever since.
FDA issues can in many cases make or break a company’s success. Among life science companies, success is not just about dollars: the availability of life-saving and improving technologies hangs in the balance.
As a result, I believe that delivering business-practical advice in plain English is essential.
Since beginning my practice in Washington, DC in 2003, I have helped numerous life science clients develop strategies for product commercialization and helped them establish proactive compliance programs, investigate and assess potential non-compliance and carry out correction and remediation of non-compliance.
I have a particular interest in Quality Systems and good manufacturing practices (GMPs), having followed an evolution in the enforcement environment bringing these topics to the forefront. GMP failures have the potential to create significant exposure, with the government pursuing increasingly creative theories in prosecuting alleged violations.
I have also focused on potential compliance matters raised by relationships between physicians and industry, including those arising in the context of clinical research; product development; and product sales, purchasing and promotion.
Some of my earliest work related to cardiology devices, and I still cherish a love for the world of medical devices. Earlier this year I was selected by The Food and Drug Law Institute (FDLI) to serve on its Medical Devices Committee. I look forward to collaborating with FDLI representatives, FDA officials, industry members and other members of the FDA bar serving on this committee, to further the dialogue around medical device regulation.
Find Becca’s contact information here
FDA ISSUES DRAFT GUIDANCE ON QUALITY AGREEMENTS FOR DRUG MANUFACTURING
FDA guidance on Quality Agreements for drug manufacturing has been somewhat scattered, with companies left to glean FDA expectations from interpretations of the regulations, portions of a number of different cGMP-related guidance documents, 483s and Warning Letters, and informal statements of FDA policy.
In late May, FDA issued a new draft guidance for industry, “Contract Manufacturing Arrangements for Drugs: Quality Agreements.”
The draft guidance addresses – in one place – methods of defining, establishing and documenting the responsibilities of each party involved in the contract manufacturing of drugs subject to current Good Manufacturing Practice (cGMP), with special emphasis on Quality Agreements. Although FDA’s expectation of Quality Agreements has been evident in recent years, the issuance of this draft guidance is still significant.
Learn more on our blog Health Care Law Matters.
DO YOU WANT TO OWN A SECRET? WHAT YOU SHOULD KNOW ABOUT THE NEW TEXAS TRADE SECRET LAW
Meghan Paulk Ingle
Texas recently became the 47th state to adopt a version of the Uniform Trade Secrets Act (UTSA). The Texas UTSA, taking effect on September 1, 2013, aims to benefit the business community by bringing Texas trade secret law more in line with the law of other states and by bringing increased predictability to Texas’s own trade secret jurisprudence.
However, while the Texas UTSA brings a number of advantages to businesses in Texas, it contains some key variations from the model UTSA.
Learn more about these variations, which businesses should keep in mind when crafting documents and determining strategies with respect to their trade secrets.
TEXAS ENACTS TAXPAYER-FRIENDLY REVISIONS TO FRANCHISE TAX
Governor Rick Perry has signed into law Texas HB 500, which provides for certain changes to the Texas franchise tax provisions.
Among other provisions, the legislation, signed into law on June 14, authorizes an elective temporary reduction in franchise tax rates imposed on taxable margin.
Learn more about the revisions recently signed into law.
NEW ANGEL PIPELINE NETWORK CONNECTS STARTUP CLIENTS AND ANGEL INVESTORS
DLA Piper’s roots with startup companies date back to the 1960s, when a handful of lawyers came together to found legacy firm Gray Cary Ware & Freidenrich in Silicon Valley. DLA Piper is now one of the world’s largest international law firms. While we have grown significantly, our focus on assisting entrepreneurs in the development and growth of concepts into companies has remained a constant. Startups are in our DNA, and supporting the growth of emerging technology companies continues to be a primary focus of the firm.
In 2001, the firm launched the Venture Pipeline as a value-add service to build relationships with the venture community and assist our clients in raising capital. In the 12 years since then, Venture Pipeline has developed the insight and relationships to efficiently guide early-stage companies through the fundraising process. Recognizing changes in the funding landscape and increasing need for clients to raise seed capital, the Venture Pipeline recently launched DLA Piper’s Angel Pipeline, designed to help our clients as they address the funding gap between launch and venture capital. Our goal is to assemble a broad set of experienced angel investors from across the country as a resource to help grow promising seed-stage companies. There are no fees, minimum investments or other commitments associated with becoming a member of the group.
If you are an Accredited Angel Investor and are interested in extending your access to quality, pre-screened deal flow, please apply to be a member. Here is the link to our membership application on the Gust network. If you have any questions about the Angel Pipeline, please feel free to contact Ian Westberg, Senior Executive in the Venture Pipeline group.