The 2.409 page Patient Protection and Affordable Care Act, (HB 3590), passed by the U. S. Congress on Sunday, March 21, 2010  includes a section establishing at long last, a pathway for FDA approval of biosimilar versions of previously approved biological products.  This provision, Title VII- Providing Access to Innovative Medical Therapies, "prohibits the approval of an application as either biosimilar or interchangeable until 12 years from the date on which the reference product is first approved. In addition, it stipulates an additional 6 months of exclusivity for the use of reference products "in the pediatric population." 

This is considered a victory for industry associations such as BIO and PhRMA who initially sought 14 years of patent exclusivity and a disappointment to biosimilar manufacturers who would like to have settled on 7 years before entering the lucrative biologicals market and who have made the claim that such competition can drive down the cost for these miracle therapies by as much as 30%. 

Title VII is not a section of healthcare reform known to most Americans who have been trying to wrap their minds around the enormous implications of this bill as they waded through the incessant political rhetoric and partisanship in recent months. In fact, I have listened to quite a bit of debate on this bill and watched a more than a few hours of coverage on C-Span, and not once did I hear mention of Title VII. It does however, hold considerable weight for the biopharmaceutical industry as a whole and ultimately, the American patient population.(See my previous posts: Advanced Degrees: Following up On Follow-On Biologics (Sep '09) and Advanced Degrees: You Say "Generic," I Say Follow-On" (Jul '09))

News media would much rather focus on what they believe is the one and only important consideration to the American populace - insurance costs. By chasing this, and other red herrings, and essentially ignoring most other elements of the bill, the significance and implications of this Act on the future of healthcare has been clouded, if not obscured entirely. No doubt it is a monumental piece of legislation, literally and figuratively. There are a number of websites that have condensed and objectively summarized the bill for easier reading and understanding. Trouble is, most Americans won't bother to take the time to educate themselves. There's the real tragedy.

It is with great saddness  that I inform you that our industry colleague, Ed Kelly, head of the U.S. Transportation Security Administration's cargo division, died on Friday, December 4th at Inova Alexandria Hospital in Virginia as a result of complications from Legionnaire's Pnuemonia.

A longtime freight industry executive, Kelly had led TSA’s cargo security branch as general manager since September 2006. He oversaw a staff of more than 50 at the agency’s Washington headquarters as the TSA worked to implement tough new security regulations that are still being phased in across the air cargo industry.

Industry officials said his strong experience and direction of the organization helped quiet mounting frustration among carriers and shippers about TSA actions many viewed as impractical and poorly informed about cargo operations.

Ed was responsible for implementing the TSA 100% Cargo Screening Program which is set to take full effect in August 2010, and worked tirelessly with many industries, including the pharmaceutical industry, to achieve this Congressional mandate. He was instrumental in working with industry to establish the Certified Cargo Screening Facility Program within the pharmaceutical trade and was a frequent speaker at industry conferences, most recently at the IQPC Cold Chain Conference in Philadelphia last September.

My condolences to his wife, Ann, his three sons, and to his extended family.

An obituary from his hometown of Scranton, PA is available here.

Dr. David Bernstein, the highly respected regulatory and technical consultant passed away on August 18th, 2009. David's long career in the clinical trials arena extended to several biotechnology and pharmaceutical companies, providing guidance in conceptual and implementation strategy and tactics for expediting the drug development process through integrating pre-clinical formulation efforts, preparation of investigational drug supplies and scale up to commercialization activities with the clinical development plan. He acted as the principal liaison between numerous virtual organizations and their CMC contractors.

David also lectured, developed training programs and educational seminars, and founded, organized and hosted the twice-annual Pacific Region Clinical Supplies Conference (PARCS), disseminatiing, sharing and discussing technology, logistics, regulatory issues and best practices involved in implementing the Investigational Clinical Supply Process.

It goes without saying that David Bernstein has always been proud of the PARCS Conferences - always providing a first-rate, professional and valuable asset to the industry. As a colleague he was among the most knowledgable, passionate, generous, and devoted individuals in his field. As a friend he will be missed and cherished for his warmth, wit and his wisdom.

Donations in David's name can be made to:

C.E.D. Orphanage
Tony Navaro
C.E.D. Society
P.O. Box 41360
Santa Barbara, CA 93140-1360
(805) 845-8757

With only ten days to go before the new version of IATA's Perishable Cargo Regulations take affect, (July 1, 2009), I thought it would be helpful to provide links for those with questions on how and where to obtain the new regs, along with specific on the handling label  requirements (voluntary for one year, required after July 1, 2010), and provide artwork for the new handlingl label.

IATA Perishable Cargo Regulations

At the bottom of the Perishable Cargo Page are two downloads:

The new Time And Temperature Sensitive Handling Label (in multiple formats)

The new training requirements and label format