In a Forbes article, Matthew Herper lays out his ideas for five ways we could improve the FDA.

Fix 1: Pay Up

How do we expect to police a $216 billion industry on $300 million per year?

FDA Fix 2: Power Up The FDA

Give the FDA powerful sticks and carrots to compel drug companies to test their medicines more thoroughly.

FDA Fix 3: Track Side Effects

In order to make sure that medicines are safe, we need to find new ways to track existing drugs.

FDA Fix 4: Fund Drug Studies

Right now, we depend entirely on companies to test the drugs they sell us. That’s not smart medicine, and it’s bad economics too.

FDA Fix No. 5: Forget Labels

Adding warnings to drugs has a limited effect. Does the FDA need its own ad agency?

As the author points out, this is only an agency that regulates products that make up a quarter of every dollar Americans spend annually–some $1 trillion in total.

More here.

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For those who always appreciate that "extra" day to get a filing in, the USPTO will be closed on Monday, 17 January (Martin Luther King Day) and again on Thursday, 20 January (Inaugural Day).

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Health and Human Services today announced steps HHS can take to advance medical innovations and move products more quickly from the lab bench to the bedside.  The recommendations were outlined in a new report: "Moving Medical Innovations Forward — New Initiatives from HHS."

The HHS task force examined internal procedures at agencies across the department, including the Centers for Disease Control and Prevention (CDC), the Centers for Medicare & Medicaid Services (CMS), the Food and Drug Administration (FDA) and the National Institutes of Health (NIH).

The report made several specific recommendations:

      Improving cooperation with other federal agencies that play a role in medical technology development.

      Creating a forum that will serve as a sounding board for investigators and manufacturers to communicate with HHS agencies.

      Supporting the ongoing development of standard formats for electronic clinical trial data.

      Improving collaboration between CMS and FDA.

      Supporting new inter-agency scientific education and cross-training efforts to identify knowledge gaps among those serving in the technology transfer functions in HHS.

The report is available here.

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This topic has been kicked around so long it seems like it, like trickle-down economics, is an ideal that is always just out of our grasp.  But, I will at least pass along that the "Committee Oversight Plan 108th Congress" website for the U.S. House of Representative’s Subcommittee on Courts, the Internet, and Intellectual Property describes plans to consider a world patent.  Under Article III, U.S. Patent and Trademark Systems, the document describes:

"Single, Low-Cost World Patent. The cost to U.S. companies and inventors of applying for and obtaining separate patents in each of 150 or more countries is prohibitive. In developing countries and even in Europe, patent fees are at such high levels that they constitute a tax on innovation. European government fees to obtain and maintain a patent are more than ten times the fees in the U.S. In addition, the expense of retaining separate patent attorneys or agents in each foreign country is burdensome and expensive. The United States could take a leadership role in negotiating an agreement under which countries would give full faith and credit to patents granted by an international organization or one of the three largest patent offices in the world- the U.S. Patent Office, the European Patent Office, or the Japanese Patent Office. Countries giving full faith and credit would charge a minimal fee for patenting in that country, and it would be unnecessary to retain separate patent attorneys or agents to obtain a patent in that country. The obstacles to negotiating and implementing such an arrangement would be formidable, but a single low-cost world patent is the best long-term approach to obtaining effective world-wide patent protection for U.S. companies and inventors. "

Starting with the Big Three (USPTO, EPO and JPO) makes a lot of sense, though.

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The USPTO has released an interim rule of practice that implements provisions of the CREATE Act that amended 35 U.S.C. 103(c). (Published at 70 FR 1818). The purpose of the Act is to promote cooperative research, such as between a university and start-up company by excluding prior art from obviousness (103) consideration if the prior art arose from a joint research agreement.

To overcome a rejection under 35 U.S.C. 103(a)based upon subject matter (whether a patent document, publication, or other evidence)which qualifies as prior art under only one or more of 35 U.S.C.102(e),(f)or (g) via the CREATE Act, the applicant must provide a statement to the effect that the prior art and the claimed invention were made by or on the behalf of parties to a joint research agreement within the meaning of 35 U.S.C.103(c)(3), and that the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement. 35 U.S.C.103(c)(3) defines a “joint research agreement” as a written contract, grant,or cooperative agreement entered into by two or more persons or entities for the performance of experimental, developmental, or research work in the field of the claimed invention, that was in effect on or before the date the claimed invention (under examination or reexamination) was made.

In addition to providing a statement, the applicant must also:

(1) Amend the specification to disclose the names of the parties to the joint research agreement;and

(2) either amend the specification to either set forth the date the joint research agreement was executed and a concise statement of the field of the claimed invention, or specify where (i.e., by reel and frame number) this information is recorded in the assignment records of the Office.

The new rules cannot be used to overcome rejections based on anticipation. Likewise, the PTO indicated that the new rules will likely not apply to reissue applications that were initially granted prior to December 10, 2004.  The PTO is asking for comments before issuance of the final rule.  Send comments to: by February 10, 2005.

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Splashlogo Girindus America is hosting an Oligonucleotide Technical Symposium being held in conjunction with the inauguration of their new commercial scale oligonucleotide facility. This symposium is co-sponsored by the Genomics Research Institute and the Cincinnati chapter of the American Chemical Society.

The Symposium will be March 9, 2005, at the Genomics Research Institute Auditorium in Cincinnati, Ohio. They have assembled an international team of oligonucleotide experts who will present during this one day symposium. There is no charge for the conference but there is a nominal charge for the ACS dinner that can be paid prior to the dinner.

There are a limited number of openings for the conference so reserve a place at the symposium by emailing your response to Ms. Rose Hawkins.

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I thought I’d post an update since I was making a donation today and thinking about the victims of the tsunami. The American Red Cross today announced a massive relief plan for those affected by the tsunamis, requiring an estimated $400 million to respond to both immediate and long-term needs now and years into the future. The plan calls for specialized relief in five areas, including food and safe water, healthcare and disease prevention, immediate family supplies, mental health counseling, and disaster preparedness and prevention measures.

The first priority for the American Red Cross is providing lifesaving help in the form of food, clean water, and sanitation, and other relief items like tents, hygiene kits and cooking utensils. Teams of American Red Cross experts have already been deployed to some of the affected areas, and are working hard to provide support to the ever-growing relief effort. Implementation of this plan has already begun in coordination with the International Federation of Red Cross and Red Crescent Societies and other important partners.

The American Red Cross will work in partnership with other relief organizations in a massive immunization campaign, while offering mental health services to those who have been so profoundly affected by this immense disaster.

Donate here.

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The New York Times ran an article promoting the idea of a risk-based protocol for safety evaluation that would greatly reduce the time and costs involved in developing most new gene-spliced crops. The author warns that alarmist warnings about the possible hazards of gene splicing have made the public extremely wary of this selective form of genetic modification even though such warnings have so far been groundless.

The article cites a telephone survey of 1,200 Americans released last October by the Food Policy Institute at Rutgers University, 43 percent thought, incorrectly, that ordinary tomatoes did not contain genes, while genetically modified tomatoes did. One-third thought, again incorrectly, that eating genetically modified fruit would change their own genes.

Most worrisome is that the European Union has banned imports of all foods produced through gene splicing, and it has kept many nations, including those afflicted with widespread malnutrition, from accepting even donated gene-spliced foods and crops by threatening to cut off products they export because they might become contaminated with introduced genes. Uganda has even prohibited the testing of a fungus-resistant banana created through gene splicing, even though the fungus is devastating that nation’s most important crop.

However, among foods developed through conventional methods to induce mutations, e.g., lettuce, beans, grapefruit, rice, oats and wheat, none had to undergo stringent testing and federal approval before reaching the market. Only those foods produced by the specific introduction of one or more genes into the organism’s DNA are subject to strict and prolonged premarketing regulations.

Read the article at here.

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