Law under the Microscope

Treatments for Kids

There have been a couple items in the news about the FDA's Pediatric Advisory Committee's recommendations that I've found interesting.

One was for the use of anti-depressants for children, in which the advisory panel strongly recommended a "black box" warning on all anti-depressants. The Panel stated that no pharmaceutical company that has an anti-depressant on the market had provided conclusive evidence that its medication is not harmful to children. Only Prozac is actually approved for pediatric care, but many physicians still prescribe other anti-depressants "off-label." The "black box" label will include a very strongly worded warning for all doctors that side effects of the anti-depressant may include increased suicidal thoughts and suicide. The pharmaceutical companies are, of course, concerned that this may lead to fewer prescriptions of the drugs. The American Psychiatric Association has expressed its concern that the warning may keep some doctors from prescribing a drug for a child that could be helpful because of the increased liability risk (one can only imagine the opening statement of the attorney of parents of a depressed child who killed himself after being prescribed the drug), or that it might keep some parents from seeking help for their depressed children.

NIH to Publish Papers

After a few months of hearing comments from research journal papers, the NIH has revealed its plan to publish papers from research funded by NIH grants. NIH's first plan to publish papers that appear in peer-reviewed journals as soon as those papers were available online. The journal publishers protested, stating their business would be drastically affected by immediate open access to the papers. The final plan presents a compromise with the publishers, and NIH will publish papers from those journals six months after they are published. The compromise has drawn fire from, among other entities, the Public Library of Science, which was advocating for immediate publication by the NIH to allow scientists and researchers access to research that affects their own endeavors.

Battle Brewing

There seems to be something of a battle brewing in the research and development of complex proteins, especially human growth hormones. The FDA punted on Sandoz's application for Omnitrop, a human growth hormone.

As noted in the article, Pfizer filed a Citizen Petition with the FDA, asking the FDA to deny Sandoz's application for Omnitrope (a follow-on of Pfizer's drug, Genotropin). Sandoz responded, saying the allegations were without merit and that its product was just fine as is. Last week, Pfizer responded to Sandoz's letter, again said that the FDA should deny the Omnitrop application or at least defer action until after the FDA's public hearing in September on guidance for follow-on biologics.

Stay tuned to see how the words keep getting slung around, and what the FDA comes up with after the hearings ....

No March-In for Norvir

Yet another chapter in the saga related to patent rights, and specifically, march-in rights, came to a close on Wednesday as NIH officially turned down the requests of certain Congressmen and AIDS advocacy groups to exercise march-in rights to Norvir, Abbott Labs’ blockbuster AIDS drug.

Faster Than a Speeding Bullet

While no company has yet found the "silver bullet" that will eradicate HIV or AIDS, the FDA's approval of a retroviral therapy and a cosmetic therapy for people with HIV/AIDS show again that its fast-track program for drugs and other therapies for people with HIV or AIDS is a real showpiece. Like any of the government agencies plagued with the reputation for slowing down the progress of business and innovation (see, e.g., the PTO), the FDA at least does have some proof that when it really wants to speed up its mandated activities, it is up to the task. Even more than just boosting the potential bottom line of the drug manufacturers in this case, they've sped the distribution of desperately needed medication to millions of people.

FDA's Game Plan for the Next Six Months

Today, the Acting Commissioner for the FDA, Dr. Lester Crawford, outlined the FDA's plan for priority actions over the next six months at a National Press Club luncheon and gave us a glimpse at the new regulations to anticipate. In very brief summary, the FDA is going to continue to work to do what it does faster and more efficiently. To no surprise, the Critical Path Initiative, which is looking to find out what the FDA can implement to make medical product development efforts more efficient topped the list, as did the information technology program that was recently outlined by Secretary Tommy Thompson (more on that program in a later blog report - I am currently digesting it's contents).