Bioelectronics Corp (BIEL)

[Dubb10]

I'd say that folks should also contact Minnesota Lawmakers for this movement. They have been on the FDA's case with respect to Med Devices.

Senator Amy Klobuchar: http://klobuchar.senate.gov/
Senator Al Franken: http://www.franken.senate.gov/
Congressman Chip Cravaack: http://cravaack.house.gov/#dialog
Congressman Tim Walz: http://walz.house.gov/
Congresswoman Michele Bachmann: http://bachmann.house.gov/
Congressman Keith Ellison: http://ellison.house.gov/
Congresswoman Betty McCollum: http://mccollum.house.gov/
Congressman John Kline: http://kline.house.gov/
Congressman Collin Peterson: http://collinpeterson.house.gov/
Congressman Erik Paulsen: http://paulsen.house.gov/



Minnesota Lawmakers Want Answers From FDA On Med Devices

By Timothy Hay

Lawmakers from the state of Minnesota, where some 400 medical technology companies are headquartered, have added to the chorus of voices claiming that undue delays by the Food and Drug Administration have stifled innovation and caused a number of young companies to close up shop or move overseas.

But the agency says the companies themselves make mistakes that add to delays and costs.

In a letter to FDA Commissioner Margaret Hamburg, Sens. Amy Klobuchar and Al Franken and U.S. Reps. Erik Paulsen, Collin Peterson, John Kline, Betty McCollum, Keith Ellison, Michele Bachmann, Tim Walz and Chip Cravaack asked for an explanation from the agency for a recent, steep drop in approvals for Investigational Device Exemptions.

IDEs are a precursor to getting new medical devices approved. In the IDE process, regulators tell applicants what types of clinical data will be necessary before moving forward with a consideration for approval.

The lawmakers’ letter to the agency said IDEs approved in an applicant’s first go-around with the agency dropped by 43% from 2009 to 2010, continuing a decade-long decline. That means that a much larger number of applicants are being sent back to the drawing board before getting clear guidance on what the FDA will require.

The letter echoes issues raised in a recent VentureWire exclusive, which cited complaints lodged by the Medical Device Venture Council, a group of life sciences investors from nine prominent venture firms who claim that unwarranted delays in the IDE and other processes is forcing their portfolio companies into shutting down or moving to Europe.

The FDA, which has experienced pressures related to staff turnover and budget fluctuations, has acknowledged that it may need to tighten up some aspects of its approval process.

But the agency also puts much of the onus back on industry, saying applicants often submit shoddy applications, or propose poorly designed studies of their technology.

“Failure to get it right up front leads to wasted time and money on the part of companies and the FDA, delays product approvals (if approval is warranted) and exposes patients to unnecessary risks by participating in clinical studies that are of no, or limited, value,” a statement from the agency said.

Addressing criticism of its IDE process and subsequent approval processes, the agency listed a number of common problems that cause regulators to put the brakes on.

Applicants often have trouble adequately describing their device, the FDA said. Applications are also often lacking predicate comparisons, which are needed if the proposed device resembles another device already on the market, according to the statement.

Applicants often leave off biocompatibility information, the FDA said. Instructions on how the device is to be used are also frequently missing.

In the 510(k) process –- for devices that have a predicate already on the market –- 60% of submissions receive two or more requests from the FDA for additional information, often because they do not address guidance documents, according to Christy Foreman, director of the FDA’s Office of Device Evaluation.

The agency said that, in a minority of cases, regulators add to delays by asking for information that is later shown to be irrelevant to the case at hand.

But that is in a slim minority of cases, the agency said in another statement.

“ … Total review times have either remained the same or increased for many applicants primarily due to industry conducting poor-quality clinical studies or submitting poor quality applications, including those that don’t follow current guidance or provide an alternative approach or don’t provide any performance data when such testing has been conducted for that device in the past,” the statement said. “Expending agency resources on poor quality submissions creates unnecessary inefficiencies.”

http://blogs.wsj.com/venturecapital/2011/07/05/minnesota-lawmakers-want-answers-from-fda-on-med-devices/