Alzheimer’s disease (AD) represents a large and growing public health crisis that demands a fast-tracked response to developing new drugs. Two doctors from the Food and Drug Administration (FDA) published a statement this week in The New England Journal of Medicine (NEJM) that made the federal agency’s case for relaxing some of the requirements needed to test and approve new drugs for the condition.

Nicholas Kozauer and Russell Katz, both medical doctors, said that the FDA has focused increasingly on patients who don’t yet show symptoms of the disease in an effort to stop AD’s development in its tracks. The attempt to develop drugs that treat advanced cases has been, in a word, “disappointing.”

According to their proposal, in the past the FDA has required researchers to prove that any new Alzheimer’s drugs improve daily function as well as preserve or recover memory and cognition. When doing studies on patients who haven’t yet lost any ability to function on a day-to-day level, this criterion would be impossible to meet. Hence, this rule can and should be relaxed without any harm to drug testing studies or to patients participating in the clinical trials.

New York Times science Gina Kolata said that other researchers have agreed. The older regulations crippled innovation, according to Dr. Eric Siemers, a researcher on Alzheimer’s disease for drug giant Eli Lilly & Company. “This is really a huge advance. Kudos to the FDA,” he said to Kolata.

It might seem like regulatory nitpicking, but anything that slows down the research can be a huge problem. As The Inquistr has previously reported, the aging worldwide population means that the rates of AD could triple by 2050.

At the moment, desperate seniors and their families are often grasping at straws, trying anything from drinking green tea to getting more sleep in an effort to ward off the symptoms of Alzheimer’s disease.

[PET scans courtesy Klunkwe and the University of Pittsburgh]

Alzheimer’s Drug Approval Process Should Be Easier, Says FDA is a post from: The Inquisitr

An “interactive” insulin drug pump system made by Roche has received approval from the U.S. Food and Drug Administration.

The diabetes treatment called, the “Accu-Check Combo system,” combines a blood glucose meter with an insulin pump. These two devices are designed to exchange data in both directions via Bluetooth wireless technology, according to the Switzerland-based drugmaker. The system, which is already in use in Europe and Asia, should become available in the U.S. later this year.

Using this diabetes therapy, the meter enables the user to quickly test blood glucose levels and also allows for operating the insulin pump remotely and, by means of an easy-to-handle bolus advisor, it provides support in defining the proper amount of insulin.

A Roche official explained that “This new system is designed to support insulin pump patients in managing diabetes easily and discreetly in their everyday life.” Some 25 million Americans are said to suffer from diabetes, and about three time more are classified as pre-diabetic, in part due to rampant obesity.

The Accu-Check device contains a cartridge holding up to 315 units of insulin, reportedly the largest capacity among pumps sold in the U.S.

Reuters reports that this is the second Roche diabetes product  this year under the Accu-Check brand to get FDA approval: “In January, the FDA approved a new Accu-Chek blood glucose monitoring system.”

Roche, which calls itself the world’s largest biotech company, is said to dominate the global blood glucose monitoring market.  It is based in Basel, Switzerland, and has a workforce of 80,000 around the world.

Insulin Drug Pump Bluetooth Device Wins FDA Approval is a post from: The Inquisitr

After a whole bunch of criticism got heaped on Pathway Genomics (the maker of at-home genetic testing kits) and Walgreens, the drugstore chain has decided not to begin offering the test kits at the originally planned 6,000 of 7,500 locations Friday.

It seems that FDA concerns and a letter sent by the agency to Pathway Genomics requesting further information on the product caused Walgreens to back away from distributing the kit. Walgreens said:

“In light of the FDA contacting Pathway Genomics about its genetic test kit and anticipated ongoing discussions between the two parties, we’ve elected not to move forward with offering the Pathway product to our customers until we have further clarity on this matter,” Jim Cohn, a Walgreens spokesman, said late Wednesday.

This evening, the FDA released a letter dated May 10th requesting information validating the products’ claims. FDA Deputy Director for Patient Safety and Product Quality James Woods said that the regulatory agency hasn’t been able to identify any “clearance or approval number” for the controversial product. In the letter, Woods says:

“If you do not believe that you are required to obtain FDA clearance or approval for the Genetic Health Report, please provide us for the basis for the determination.”

Pathway responded, asserting that the kit complies with regulations:

“Pathway works very diligently to ensure that our business is compliant with all applicable regulations and guidelines,” Pathway said in a statement issued Wednesday in response to the FDA’s inquiry. “Our laboratory is federally CLIA-certified and state-licensed. We have provided the same personal genetic report to customers for the past year, and are continuing discussions with the FDA about the regulation of personal genomic information.”

It is unclear whether Walgreens will decide to carry the kits if FDA approval is obtained.

[Chicago Breaking Business via Consumerist]

Walgreens opts not to carry at-home genetic testing kit without FDA approval is a post from: The Inquisitr