Results tagged “FDA” from Drugs & Medicaments

Desmopressin acetate intranasal formulations are no longer indicated for the treatment of primary nocturnal enuresis (PNE) because of the risk for severe hyponatremia that can lead to seizures and death, the US Food and Drug Administration (FDA) warned healthcare professionals yesterday.

These formulations are currently marketed as DDAVP (sanofi-aventis US, LLC), Minirin (Ferring Pharmaceuticals, Inc), and Stimate (CSL Behring, LLC).

by Mike Adams, NewsTarget.com

The U.S. Senate Health, Education, Labor and Pensions Committee voted 15-5 to approve a bill that aims to strengthen FDA oversight of drug company advertising and post-approval follow-up studies. The bill was sponsored by Wyoming Republican Sen. Mike Enzi and Massachusetts Democrat Sen. Edward Kennedy. The primary motive for the bill is to give the FDA more power to stop a future Vioxx disaster from being repeated.

The Bush Administration is against the bill and offered sharp objections to the bill's provisions, saying it would slow down drug approvals. Republicans also argued that the banning of drug advertisements on television was "unconstitutional."

U.S. senators vowed on Wednesday to move forward with legislation to legalize the importation of cheaper prescription drugs from certain countries, despite resistance from regulators and drugmakers.

One Democrat and three Republicans said their plan would provide money and safeguards for the Food and Drug Administration to assure the imports were not dangerous.

"I believe this legislation puts in place an effective regulatory framework to make importation of FDA-approved drugs safe for consumers," Sen. Byron Dorgan (news, bio, voting record), a North Dakota Democrat, said at a hearing.

Recent problems at FDA can be attributed to the lack of consistent, long-term leadership; insufficient resources; and not enough authority to address safety issues, according to four former FDA commissioners who participated Wednesday in a panel discussion at the George Washington University School of Public Health and Health Services, the Newark Star-Ledger reports.

David Kessler, who served as commissioner from 1990 to 1997, criticized the pharmaceutical industry's use of mass-marketing techniques and direct-to-consumer advertising. "The notion that you can come up with a new drug and millions and millions of people take it safely -- the blockbuster -- that is what got us in trouble," Kessler said.

During the past several years, there has been a perceived drug safety crisis in the United States. The Institute of Medicine (IOM), recently released its final recommendations for reforming the U.S. drug safety system, but an editorial published in Health Economics by Tomas Philipson and colleagues at the University of Chicago finds little evidence of a drug safety crisis and no scientific evidence to back up the IOM's recommendations.

The current drug controversy is largely due to the withdrawal of Vioxx from the market, but the decrease in drug approval times thanks to the Prescription Drug User Fee Acts (PDUFA), and undue influence from the pharmaceutical industry that these acts may have invited have also played a role. Yet the scientific basis that too many unsafe drugs enter the market is lacking.

The U.S. Food and Drug Administration (FDA) is facing renewed criticism over the process by which it approves drugs for market. Recent reports indicate many drugs are approved before they are proven safe, and problems with the agency's structure and processes prevent it from fulfilling its mission. Subsequently, Congress has started using its oversight powers to scrutinize the agency, and the clamor for FDA reform is growing louder.

The Federal Food Drug and Cosmetic Act requires FDA to ensure the safety of new drugs before the agency approves the drugs for market. However, operating within a provision of the law, FDA often approves drugs before safety is established. The agency then requires drug manufacturers to further study drugs while they are on the market. These "post-marketing commitments" serve to streamline the drug approval process.

With a lot of fanfare, the Food and Drug Administration last week announced a first — its approval of a diet pill that can be bought without a prescription.

A lower-dosage version of the prescription drug Xenical, the over-the-counter medication will be marketed by GlaxoSmithKline and goes on sale this summer. Since nearly 130 million Americans are considered overweight, the drug is expected to be popular. Conservative estimates are that 5 million-6 million Americans will use the drug in its first year.

Since obesity has been identified as a worsening problem in the United States, this news could be greeted with optimism, except for the many "ifs" and "buts."

by Jerry Avorn, MD

It has become fashionable to argue that if we just let the marketplace do its thing in healthcare, quality will rise, costs will plummet, and our patients -- I mean our customers -- will prosper. But this is a bad way to organize medical care delivery, and it's an even worse way to generate information about the medications we use.

The Food and Drug Administration does not test drugs itself, instead relying on manufacturers to design and conduct the clinical trials that determine whether their products are approved or not. The companies even pay the salaries of the FDA employees who make those approval decisions. The FDA has hardly any resources to conduct its own postmarketing safety studies of drugs. Instead, it asks the manufacturers to do them -- and most of the studies it requests are not done.^[1,2]

Scientists who have worked at the U.S. Food and Drug Administration and criticized agency decisions are now helping Congress fashion legislation to tighten product- safety rules.

The scientists include David Ross, who said in an interview that FDA supervisors forced him to retract a recommendation that the antibiotic Ketek, made by Sanofi-Aventis SA, was probably too dangerous to be used for treating two common respiratory infections. The drug was approved in 2004 and had $148 million in sales in 2005.

Ross is one of four current or former employees of the FDA who are working with Congress on bills intended to create more stringent drug safety rules. One change being proposed would create a new office to monitor the safety record of drugs after they're on the market. Next week, several of the critics will state their concerns at a congressional hearing into the FDA.

MONDAY, Feb. 5 (HealthDay News) -- President Bush's proposed $2.9 trillion federal budget, unveiled Monday, calls for health care spending cuts, including a major five-year reduction in Medicare expenditures to slow the program's annual growth rate from 6.5 percent to 5.6 percent.

The proposed total cuts of $78 billion for Medicare and Medicaid -- the federal health insurance programs for the elderly and lower-income Americans, respectively -- are part of Bush's plan to eliminate the federal deficit by 2012. However, Medicare spending would increase nearly $454 billion in 2008, an increase of $28 billion over this year, before the proposed reductions take effect.

The total 2008 budget for federal health care, administered by the U.S. Department of Health and Human Services, would be nearly $700 billion for the fiscal year that begins Oct. 1, an increase of more than $28 billion over 2007. Medicare makes up 55.4 percent of the HHS budget, while Medicaid accounts for 29 percent.

WASHINGTON -- The Bush administration yesterday proposed about a $100 million increase in the Food and Drug Administration's budget for fiscal 2008 that includes the first user fee for the generic drug industry as well a big boost in fees paid by brand-name pharmaceutical companies.

The FDA said the budget increase will be devoted to improving the screening and safety of new drugs; stepped-up oversight of medical devices; strengthening of food safety in light of recent food- borne outbreaks; and more timely reviews and approvals of lower-cost generic drugs.

The President's blueprint calls for $2.1 billion in overall FDA spending during fiscal 2008, up from a projected $2 billion for the current fiscal year.

By GARDINER HARRIS, NY Times

The Food and Drug Administration announced changes yesterday that were intended to ensure that marketed drugs are as safe as advertised, including the first effort to do a comprehensive assessment of the safety of drugs 18 months after introduction.

The agency also announced the creation of an advisory panel to improve the way it announces safety worries and a collaboration with the Veterans Health Administration to track how real patients fare after taking drugs.

By Evelyn Pringle

Over the past year, the Bush administration's FDA has been the focus of non-stop investigations and with the Democrats in control of Congress, a long overdue overhaul of the agency is in the cards.

The Government Accountability Office has identified serious problems within the FDA. In an April 21, 2006, report, the GAO found the FDA's performance "disorganized," "bureaucratic," and undermined by infighting between drug evaluation administrators whose allegiance is with the pharmaceutical industry, and the Office of Drug Safety.

According to the GAO, the drug safety office is under-funded, lacks independence and lacks decision-making responsibility. It also criticized the way FDA scientists were prevented from speaking at advisory committee meetings on drugs they were studying.

WASHINGTON, Jan. 11 /PRNewswire-USNewswire/ -- A proposed user-fee deal negotiated in private between the pharmaceutical industry and the FDA earmarks some funds for drug safety, but Consumers Union says the Administration must significantly fund comprehensive safety efforts, and Congress must pass new laws, to adequately protect the public from dangerous drugs.

"At a time when countless drugs have safety problems, it isn't enough to just rely on money paid by the pharmaceutical industry to fund needed drug safety reforms," said Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports.

"To address the wholly inadequate drug safety system, consumers need a commitment from the Administration to completely fund drug safety, and new laws that will ensure we don't have any more Vioxx-type disasters," Vaughan said.

WASHINGTON--(BUSINESS WIRE)--The recommended improvements to the Prescription Drug User Fee Act (PDUFA) announced today by the Food and Drug Administration (FDA) will allow continued enhancement of FDA’s post-market safety capacity and help ensure careful, timely and transparent review of new drugs and biologics, said the Biotechnology Industry Organization (BIO). The FDA’s recommendations come as a result of extensive discussion and input from industry, as well as patient organizations, consumer groups and other stakeholders. Since its inception in 1992, PDUFA has helped to enable FDA to approve more than 1,100 new medicines and reduced review times for innovative drugs and biologics, providing patients and doctors with earlier access to breakthrough treatments. The current PDUFA agreement is set to expire on September 30, 2007.

“The PDUFA recommendations announced today are a win-win,” said BIO president and CEO Jim Greenwood. “If enacted, they will help enhance and improve drug safety while providing resources to continue to enable efficient and comprehensive review of new drugs. These proposals underscore our industry’s commitment to ensuring the government has the needed resources to complete safety reviews for new drugs and biologics in a timely manner.”

WASHINGTON--(BUSINESS WIRE)--The recommended improvements to the Prescription Drug User Fee Act (PDUFA) announced today by the Food and Drug Administration (FDA) will allow continued enhancement of FDA’s post-market safety capacity and help ensure careful, timely and transparent review of new drugs and biologics, said the Biotechnology Industry Organization (BIO). The FDA’s recommendations come as a result of extensive discussion and input from industry, as well as patient organizations, consumer groups and other stakeholders. Since its inception in 1992, PDUFA has helped to enable FDA to approve more than 1,100 new medicines and reduced review times for innovative drugs and biologics, providing patients and doctors with earlier access to breakthrough treatments. The current PDUFA agreement is set to expire on September 30, 2007.

“The PDUFA recommendations announced today are a win-win,” said BIO president and CEO Jim Greenwood. “If enacted, they will help enhance and improve drug safety while providing resources to continue to enable efficient and comprehensive review of new drugs. These proposals underscore our industry’s commitment to ensuring the government has the needed resources to complete safety reviews for new drugs and biologics in a timely manner.”

Before you buy a car, would you want to know how many complaints people had made to the manufacturer about defects, or how many warranty claims had been paid, or how many dealers had reported problems with the vehicle?

Federal law says you have a right to such info. But the Bush administration and the auto industry are quietly trying to change that.

In 2000, Congress passed the Transportation, Recall Enhancement, Accountability and Documentation Act to address regulators' failure to spot defects in Firestone tires that were linked to numerous deaths.

by Dani Veracity

Last year, Public Citizen, a national non-profit public interest organization, exposed that while conflicts of interest at the FDA's drug advisory committees are common and often have serious dollars at stake, advisory committee members and voting consultants rarely step down because of them. If a new conflict-of-interest amendment by Congressman Maurice Hinchey, D-NY, goes through, this will soon change for the better.

The foundation of the American drug approval process is theoretically objective science; however, the very nature of the process often allows subjectivity to come into play. In order for a new pharmaceutical to be approved by the FDA, the Center for Drug Evaluation and Research (CDER) looks at the pre-approval clinical trials paid for by the drug's maker and determines whether the drug is safe and effective. This is done at a rate of 25 to 30 new pharmaceutical drugs per year, according to Public Citizen.

This week marks the 100th Anniversary of the implementation of the Pure Food and Drug Act, a landmark piece of legislation calling for federal inspection of food products and paving the way for the creation of the Food and Drug Administration. However, as a January 2 New York Times editorial points out, advances in food safety are far from adequate considering how much time has elapsed.

Though nearly a century had passed, 2006 may have been the nadir of the federal food safety era. A spinach contamination outbreak in the fall killed three, and mysterious Taco Bell food poisonings only aggravated national concern. The Times editorial points out that anti-government conservatism has been a contributing factor in the declining safety:

Jan. 2 (Bloomberg) -- A consumer group said U.S. food regulators have backed away from plans to limit a cancer-causing byproduct that forms during the baking or frying of foods, including products from PepsiCo Inc., the largest U.S. maker of salty snacks.

The group, the Center for Science in the Public Interest, based in Washington, sent a letter to U.S. Food and Drug Administration Commissioner Andrew C. von Eschenbach on Dec. 1, urging him to follow through on agency promises to limit acrylamide. Swedish scientists discovered in 2002 that the substance develops in carbohydrate-rich foods, such as potatoes and breakfast cereals.

After initially reporting variations in acrylamide levels in branded products within the same food categories, the FDA has stopped publishing the information, and food makers refuse to provide it to the public, said Michael F. Jacobson, executive director of the Center. He said the FDA isn't reporting test results or setting limits.