Chairman's Message

It seems hard to believe that 2009 is already more than a month old.  The FMMC started the new year with a successful Executive Briefing featuring Dr. Marshall Goodman, CEO of USF Polytechnic who gave a very thought provoking presentation on the state of university education in the United States and the role he sees for USF Polytechnic.

Geary A. Havran

FMMC Chairman

 March Executive Briefing

Intellectual Property: 

Protecting Yours and Succeeding at Competitive Intelligence

Tuesday, March 17, 2009

FMMC Executive Briefing/Breakfast

Feather Sound Country Club
2201 Feather Sound Drive 
Clearwater, FL 33762

Ballroom A

7:30 am - 8:00 am - Registration and Networking
8:00 am - 9:00 am - Breakfast and Presentation

Sponsored by:

Please visit STAR Technology Enterprise Center
by clicking www.STARTECflorida.com.

For more information please click www.FlaMedMfg.org.

_______________________________________________

Sponsorships Available
 
FMMC Executive Briefing/Breakfast Sponsorships and 2009 Florida Medical Device Symposium Sponsorships are available to member companies. Both of these sponsorships afford FMMC member organizations an opportunity to support FMMC, facilitate networking, and educate the Florida Device Industry about your company's products and services.

For more information on sponsorships or for information about joining and becoming a member of the Florida Medical Manufacturers' Consortium please contact Lisa Kamper at 866-437-6534 or info@FlaMedMfg.org.

Florida Medical Device Symposium

The Annual Event Presented by Florida Medical Manufacturers' Consortium, Inc.
 
April 7-8, 2009

Florida's premier event for medical device companies includes presentations by nationally recognized speakers, industry panel discussions on regulatory issues and outsourcing, legislative updates and networking opportunities.

Be sure to mark your calendar and reserve your room as this is an event you will not want to miss! FMMC is excited to bring you exemplary educational sessions, dedicated networking time, and vendor displays!

Hotel Reservations

To make a reservation, call Marriott Tampa Waterside Hotel & Marina at 800-228-9290 and request a room for the Florida Medical Device Symposium to receive the special room rate of $199.00.  To receive this special rate, reservations must be made by Friday, March 13, 2009. 

Click Here To Register Today! 

For more information on the Symposium click www.flamedmfg.org/symposium.cfm 

Click here to visit Tampa Marriott Waterside

Membership News 

FMMC Welcomes New Member

Mercury Medical is a comprehensive health care company specializing in anesthesia, respiratory and critical care products and services and is recognized for its excellence in manufacturing high quality medical devices.

Mercury's core business encompasses Hospital Sales, Biomedical Clinical Services, Mercury Medical Manufactured Products (MMP), International, Medical Gas Certification, Rental Equipment and Alternate Site Businesses (Home Care and ShurShip.)

Within the Hospital Sales division, Mercury Medical represents several highly technical life support manufacturers exclusively within a eleven-state territory, including; Alabama, Arkansas, Florida, Georgia, Maryland, Mississippi, North Carolina, South Carolina, Tennessee, Virginia, and Washington D.C. It maintains a similar role with manufacturers of disposable and commodity products in the areas of anesthesia, respiratory and critical care.

Mercury Medical is headquartered in Clearwater, Florida with a regional depot in Atlanta, Georgia. These locations maintain a five-million dollar inventory of equipment and repair parts.

NDH Medical, Inc. Expands 

NDH Medical, Inc. has recently expanded its manufacturing operations to accommodate existing and planned sales growth.  With over double the space, and the addition of new extrusion capacity, the firm is now able to supply tubing in sizes up to 1 inch in diameter in a wide array of medical grade polymers.  Additional value added manufacturing steps, such as tip forming, printing, assembly, insert molding, and packaging are available to meet turnkey outsourcing requirements.

Capitol Notes 

by John Ray 

Special Session Report
The New Year ushered in more budget-cutting in Tallahassee as the Florida Legislature convened in special session earlier this month to tackle Florida's ballooning $2.3 billion budget deficit.   During the 10-day special session, most government programs received sizeable reductions, including K-12 education, university research, and social services, among others.  Though there are no reductions to Medicaid eligibility or services, the budget bill does lower reimbursement rates in several categories, including about $100 million in cuts to hospitals through a 4 percent reimbursement reduction for inpatient and outpatient care.  Overall, the $2.6 billion package includes more than $1 billion in combined cuts, coupled with an additional $1.6 billion from Florida's "rainy day" fund, the Chiles Endowment, and numerous existing trust funds.  On January 27th, Governor Crist signed the budget bill (SB 2A) into law, but not before using the line-item veto to restore nearly $91 million in funding for public safety, K-12 education, the Florida Forever land conservation program, and economic development, among other programs.

However, the Special Session of the Florida Legislature was not exclusively about reducing the budget.  Governor Crist proposed and the Legislature passed "Economic Gardening" legislation, a pilot program providing $10 million in small business loans and technical assistance to expanding Florida companies.  The new program will provide low-interest (2%) loans up to $250,000 for 4 years to expanding businesses in this state that: reside within a State target industry sector (medical device companies qualify); employ between 10-50 persons; have maintained their principal place of business in the state for the past 2 years; generate at least $1 million but not more than $25 million in annual revenue; and, during 3 of the previous 5 years, have increased both its number of full-time equivalent employees in this state and its gross revenues.  Eligible recipients may use the loans for working capital purchases, employee training, and salaries for new job creation.  The FMMC will provide further updates as this program is rolled out and implemented.

With the beginning of the regular legislative session slated for March 2nd, Florida's revenue picture is not getting any brighter and deeper budget cuts are on the horizon.   It is estimated that the budget hole for the 2009-10 fiscal year could approach $4 billion.  Thus, it appears the Governor and lawmakers will have to consider the "revenue" side of the equation, instead of just the "spending" side, to balance the state budget.  While new taxes are not likely to be supported (save perhaps an increase to the cigarette tax), Florida's existing tax exemptions and "loopholes" will receive close scrutiny as potential ways to recapture revenue to address our large budget deficit.  As we all know, not all tax exemptions are created equal or deliver equal benefits to the economy, so the FMMC intends to work hard this session to ensure that hard-fought tax policies, such as the sales tax exemption on new machinery and equipment, are preserved.

The newly-created Florida Senate Select Committee on Florida's Economy began meetings and field hearings in January, to uncover ideas and recommend new policies to stimulate Florida's economy and create new jobs.   Led by Chairman Don Gaetz (Ft. Walton Beach), the primary objectives of the Select Committee are to identify government-controlled barriers to economic recovery; to remove or reduce redundant or non-essential regulatory activities; and to develop policies and incentives to encourage business development.   The committee will also conduct a review and assessment of Florida's tax structure, to perhaps include a closer look at tax exemptions. 

The FMMC will continue to monitor the work of this committee and update the membership on future meetings and scheduled field hearings.
Workers' Comp Rates:  As reported previously, predictions of rising workers' comp rates in the wake of the Florida Supreme Court ruling (reversing limits on attorneys' fees) have proven to be accurate.  On January 26th, the Florida Office of Insurance Regulation approved a 6.4 percent increase in worker's comp premiums effective April 1, 2009.  The Florida Legislature will likely attempt to address this issue and worrisome trend during the upcoming regular session.  The FMMC intends to support this legislative effort.

FDA Law Blog

"Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices."

By: Alan M. Kirschenbaum

 
The heart of the guidance sets forth FDA's recommendations for the content, type, and manner of distribution of reprints and texts, which are largely unchanged from the draft.  According to the guidance, the types of permissible journal articles are those that:

 
· Are published by an organization with an      independent, expert editorial board and a publicly stated policy on conflicts of interest.
· Are peer reviewed.
· Are not false or misleading.  Examples of false or misleading articles are those that have been withdrawn by the journal or disclaimed by the author, or that report on studies that are inconsistent with the weight of credible evidence.
· Do not pose a significant health risk, if relied upon.
· Are not special supplements funded by the manufacturer, letters to the editor, abstracts, or reports of phase 1 studies in healthy subjects.

FDA's recommendations for distribution, which also remain largely unchanged from the draft, are that the journal article or text should:

· Be unabridged and not marked, highlighted, summarized, or characterized by the manufacturer in any way.
· Be accompanied by the approved labeling.
· Be accompanied by a comprehensive bibliography of publications discussing studies on the unapproved use, when such information exists.
· Be disseminated with a representative publication (if any) that reaches contrary conclusions on the unapproved use.
· Be distributed separately from promotional information.
· Not be distributed in a promotional exhibit.
· Not be the subject of discussion between a sales rep and a physician during a visit.  A footnote explains that sales reps should refer questions to company medical staff, which should be separate from the sales or marketing departments.

Under the final guidance (as under the draft), the reprint or text should be accompanied by a prominently displayed statement disclosing that the uses discussed have not been approved or cleared, and disclosing the manufacturer's interest in the product discussed,  and any author known to have a financial interest in the product or manufacturer or known to be receiving compensation from the manufacturer. Going beyond the draft, the final guidance adds that the amount of the financial interest or the compensation and the affiliation of the author should also be disclosed, if known.

Other Events & News

2009 FMMC Calendar of Events
 
Mark your calendar!