Von eschenbach: funds needed to fulfill fda mission

WASHINGTON -- Food and Drug Administration Commissioner Andrew von Eschenbach called for sweeping changes to the agency under his watch during a speech delivered at National Press Club earlier this month.

And perhaps for first time, von Eschenbach broke ranks with Bush administration in acknowledging that the Food and Drug Administration is facing a budget crisis that'll continue to impede FDA's ability to complete its mission -- and that is to protect the American public.

" The simple truth as I see it today is that Food and Drug Administration of 20th century is not adequate to regulate the food and drugs of 21st century, " he said. " This is a time in which winds of change in health care in terms of power and pace aren't a gentle breeze but a jet stream. And the Food and Drug Administration must respond to these changes if it is to continue to fulfill its mission of protecting and promoting your health. "

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And with that statement von Eschenbach affirmed FDA critics' worst fears -- agency doesn't have money to do its job today, and it's not getting it tomorrow. Last month, the FDA received a 5. 7 percent budget boost for fiscal 2009, bringing agency's total budget to $2. 4 billion. A November 2007 Science Board report, a report actually commissioned by FDA, called for a 15 percent increase for 2009, which would have brought Food and Drug Administration total budget to $2. 6 billion.

The sweeping changes that von Eschenbach called for would necessarily require a significant influx of capital to implement, and von Eschenbach publicly called for that need to bolster the FDA with additional funding. " It's no secret in Washington that as FDA's responsibilities have grown, the resources devoted to them haven't kept pace, " he said. " Strengthening Food and Drug Administration for this new century will require an investment, providing our agency with a budget and authorities that are commensurate with the scale and scope of our mission. We're on a trajectory of budget increases granted by Congress in 2007 and 2008 and those proposed by president for 2009. This trajectory must continue and, as justified, must accelerate, " he said. " We cannot transform agency ourselves. "

Already, von Eschenbach has re-engineered internal processes at FDA to make the agency more efficient and better prepared to rapidly respond to healthcare concerns with implementation of a few guiding principles.

The principles of systemic change process included focusing FDA's workflow to address most immediate concerns -- drug safety, food protection, FDA's scientifically-inclined labor pool and infrastructure ( including $250 million in the 2009 budget earmarked to improve FDA's dated information technology infrastructure ) . The principles von Eschenbach mentioned included a critical self-examination of the agency and whether Food and Drug Administration is delivering on its mission. And those agency critiques aren't only well under way, but have made plenty of headlines of late -- including reports coming out of Government Accountability Office and highly critical Science Board report released in November, a report that the Food and Drug Administration itself commissioned to have done.

And finally, von Eschenbach sounded more like a chief executive officer than a commissioner when outlining an FDA principle of achievable outcomes, the journey toward those outcomes marked by milestones to ensure that the agency stays on course. " We were very honored to have launched such a plan -- our Response to IOM Drug Safety report -- right here at National Press Club last year and have already implemented many of initiatives outlined in the report, such as creation of our Risk Communication Advisory committee, " he said.

Perhaps of greatest import to drug industry, von Eschenbach announced a new FDA program, to be called the Sentinel Initiative, that'll better capture postmarketing usage data.

" It's a collaborative effort with public and private partners that will create a distributed, nationwide system that will allow Food and Drug Administration to analyze large databases of information about safety of medical products as they are used by large diverse populations, " von Eschenbach said. It addresses criticism that Food and Drug Administration fails to regulate drugs once they are approved for marketing.

And to help prevent the kind of regulatory oversights of foreign-based production facilities that contributed to the recall of Baxter Healthcare's heparin products in February, von Eschenbach wants to establish satellite FDA offices in several regions of concern -- China, first and foremost, but also India, Europe, central South America and the Middle East.

Medical advises about everyday life

Do you know Viagra?

uses of Viagra Viagra is used to treat male sexual function problems ( impotence or erectile dysfunction ) by blocking a certain enzyme ( phosphodiesterase-PDE5 ) in body. In combination with sexual stimulation, Viagra works by helping blood flow into penis to achieve and maintain an erection.

Viagra isn't indicated for use in women.

Use of Viagra doesn't protect against sexually transmitted diseases ( e. g. , HIV, hepatitis B, gonorrhea, syphilis ) . Practice " safe sex " such as using latex condoms. Consult your doctor or pharmacist for more details.

how to use of Viagra Viagra is taken by mouth as needed, at least 30 minutes, but no more than 4 hours, before sexual activity ( 1 hour before is most effective ) . Don't take more often than once daily, and take as directed.

A high fat meal may delay time of onset of this drug.

Avoid eating grapefruit or drinking grapefruit juice while you're being treated with Viagra unless your doctor instructs we otherwise.

The dosage is based on your medical condition, response to therapy, and other medications you may be taking ( see also Drug Interactions section ) . Consult your doctor or pharmacist for more details.

side effects of Viagra Headache, flushing, stomach upset, heartburn, nasal stuffiness, diarrhea, dizziness, or lightheadedness may occur while use Viagra. Vision changes such as increased sensitivity to light, blurred vision, or impaired blue/green color discrimination may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed Viagra because he or she has judged that benefit to we is greater than risk of side effects. Many people using Viagra don't have serious side effects.

Rarely, a sudden loss of eyesight in one or both eyes ( NAION ) may occur while use Viagra. This may or mayn't be due to Viagra. If this serious problem occurs, seek immediate medical attention. You have a slightly greater chance of developing this serious eye problem if we have heart disease, diabetes, high cholesterol, certain eye problems ( " crowded disk " ) , high blood pressure, are over 50 years of age, or if we smoke.

Sexual activity may put extra strain on your heart, especially if we have heart problems. If we have heart problems and experience any of these serious side effects while having sex, stop and tell your doctor immediately of:

For males, in very unlikely event we have a painful or prolonged erection lasting 4 or more hours, stop using Viagra and seek immediate medical attention, or permanent problems could occur.

Rarely, Viagra may cause sudden hearing problems, or ringing in ears. Seek immediate medical attention if these effects occur.

A serious allergic reaction to Viagra is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include:

This isn't a complete list of possible side effects. If we notice other effects not listed above, contact your doctor or pharmacist.

precautions of Viagra Before taking Viagra, tell your doctor or pharmacist if we are allergic to it; or if we have any other allergies.

Before using Viagra, tell your doctor or pharmacist your medical history, especially of:

Viagra may make we dizzy or cause vision changes; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Don't take Viagra with any other product that contains Viagra or other similar medications for erection problems ( e. g. , tadalafil, vardenafil ) .

Caution is advised when using Viagra in the elderly because they may be more sensitive to side effects of the drug.

Viagra isn't indicated for use in women or children.

interactions of Viagra Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring we for them. Don't start, stop, or change the dosage of any medicine before checking with them first.

See also How To Use section for drug-food interactions.

Viagra should not be used with the following medications because very serious ( possibly fatal ) interactions may occur:

If we are currently using any of these medications, tell your doctor or pharmacist before starting Viagra.

Before using Viagra, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of:

If we are taking an HIV protease inhibitor ( e. g. , ritonavir, saquinavir ) , don't take more than a 25mg dose of Viagra in a 48 hour period.

If we are taking more than a 25mg dose of Viagra and are also taking an alpha-blocker medication ( e. g. , doxazosin, prazosin, terazosin ) for various conditions ( e. g. , enlarged prostate ) , separate the time between taking these medications by more than 4 hours.

This document doesn't contain all possible interactions. Therefore, before using Viagra, tell your doctor or pharmacist of all products we use. Keep a list of all your medications with you, and share list with your doctor and pharmacist.

overdose of Viagra If overdose of Viagra is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include severe dizziness, fainting, or prolonged erection.

notes of Viagra Do not share Viagra with others, since they may have a problem that's not effectively treated by Viagra, or they may have a condition that's complicated by Viagra.

missed dose of Viagra Not applicable.

storage of Viagra Store Viagra at room temperature at 77 degrees F ( 25 degrees C ) away from light and moisture. Brief storage between 59 and 86 degrees F ( 15-30 degrees C ) is permitted. Don't store Viagra in bathroom. Keep all medicines away from children and pets.

Properly discard Viagra when it's expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Shipping options for Viagra

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