JOLT Digest

By Sarah Sorscher*, JD/MPH Candidate, Harvard Law School &
Sara Crager, MD/PhD Candidate, Yale
Editorial Policy

Text of H.R. 1427
Summary

Last week, Rep. Henry Waxman and several other representatives unveiled the latest version of a bill designed to lower the price of drugs by encouraging generic competition in biological products (”biologics”). Biologics are products derived from living processes and used to prevent, treat, or cure human illness. Most drugs, in contrast, are synthesized using chemical reactions.  Biologics include products such as vaccines, blood-derived products, antibodies, and recombinant proteins (e.g. proteins that modulate the immune system, or proteins that induce the proliferation of red blood cells). Over the past 30 years, a revolution in recombinant DNA technology has propelled the sub-field of biologics from the periphery into prominence in the biopharmaceutical industry. Three of the top 10 best-selling drugs in the U.S. in 2007 were biologics (Enbrel, Aransep, and Epogen), and biological products now represent some of the most expensive drugs on the market; annual per-patient treatment costs for one expensive drug topped $300,000 last year.

The new bill, H.R. 1427, dubbed the “Promoting Innovation and Access to Life-Saving Medicines Act,” is intended to introduce price competition in biologics by granting the FDA clear authority to approve generic, or “follow-on” biologics, which are comparable in safety and efficacy to biologics already on the market. The new legislation is modeled on the Hatch-Waxman Act of 1984, which allowed generic manufacturers to gain market approval by showing that their products were interchangeable, or bio-equivalent, with previously approved products, without the need to preform additional clinical trials. Until now, the FDA has been reluctant to allow for this type of abbreviated approval for biologics, which have historically been regulated under a different legal regime from other drugs. Although, as described in this testimony by an FDA official, the story is more complicated. Some proteins that were initially purified from human and animal tissues, such as insulin and human growth hormone, were categorized as drugs when they first obtained FDA market approval. Today these substances remain regulated as drugs, even though they are now synthesized using recombinant DNA technology, like many biologics.
(more…)

Public Trials Should Be Made Available Via Internet
By: Debbie Rosenbaum*
Editorial Policy

File-Sharing Cases in Courts Around the World
In February, the four men behind the popular file-sharing site The Pirate Bay went to trial in Stockholm, Sweden.  They stand accused of helping millions of Internet users illegally download protected movies, music, and computer games. The defendants – Fredrik Neij, Gottfrid Svartholm Warg, Peter Sunde Kolmisoppi, and Carl Lundström – face up to two years in prison and a fine of 1.2 million kronor (US $143,529) if convicted of being accessories and conspiracy to break Swedish copyright law.  The case has made headlines not only because of the substantive legal issues, but also because Defendant Peter Sunde, co-founder of The Pirate Bay, has called for the court’s proceedings to be as open as possible. The Swedish court granted Sunde’s motion to allow coverage of the proceedings without much resistance, and SVT, a public broadcaster in Sweden, has provided streaming audio webcasts webcasts of trial.

A similar situation is unfolding in the United States in a high-profile case involving issues very similar to those of The Pirate Bay case, although here there has been significant resistance for the defendant’s calls to open the proceedings to the public.  Joel Tenenbaum is one of the tens of thousands of defendants being sued by the RIAA for allegedly violating their members’ copyrights by distributing files through P2P file sharing software. However, unlike the vast majority of the defendants in these cases, he chose to litigate rather than settle his case rather than settle, with the help of Harvard Law School Professor Charles Nesson and a team of his students. With Professor Nesson’s assistance, Tenenebaum filed a motion similar to Sunde’s, requesting his trial be broadcast live via the Internet. Tenenbaum’s motion asked the Court to exercise its discretion under the Court’s local rules to allow Internet access to the courtroom by authorizing the Courtroom View Network (”CVN“) to provide audio visual coverage of the proceedings in this case over the Internet.

(more…)

Australia Poised to Begin Internet Filtering Program Unprecedented in Scope for Modern Democracy
By Debbie Rosenbaum
Editorial Policy 

If the presumption that democracy depends upon the widest possible access to uncensored ideas, data, and opinions is true, then there is cause for great alarm as one of our nation’s closest democratic allies moves to drastically curtail this foundational freedom within its boarders. The Australian government will likely enact legislation that will make sweeping, compulsory Internet censorship a startling reality for all Australian citizens. Spearheaded by the Minister for Broadband, Communications and Digital Economy, Senator Stephen Conroy, and backed by $44.2 million from the government’s $125.8 million Plan for Cyber-Safety budget, the planned filter (part of the NetAlert program) will render Internet access in Australia similar to that in Iran or China.

Australia’s Federal Government announced its ambitious web censorship plan in December 2007. The goal of the program is seemingly well intentioned: to shield children from violent and pornographic sites. (See the Australian government’s “Children Are Sacred” report, which discusses instances of child sexual abuse in the Northern Territories). The Family First Party, a relatively minor party with only one Member of Parliament, originally championed the filter, also known as the “clean feed” policy. The Party’s proposal has earned wider support from both Senator Conroy and the Rudd-Labor Government. Senator Conroy is expected to call for bids from Australian software makers, and reportedly wants to begin live trials by the end of the year.

(more…)