Results tagged “politics” from Drugs & Medicaments

NEW YORK (Reuters Health) Mar 20 - Laws that mandate disclosure of payments to physicians by pharmaceutical companies provide limited public information, according to a new report.

At present, five states and the District of Columbia have legislation requiring payment disclosure. Among these states, Minnesota and Vermont require that the information be made available to the public.

In the current study, reported in the March 21st issue of the Journal of the American Medical Association, Dr. Joseph S. Ross, from Mount Sinai School of Medicine in New York, and colleagues examined the accessibility and quality of information provided by the disclosure laws in Minnesota and Vermont.

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.

BOSTON, MA -- March 6, 2007 -- For years, pharmaceutical companies have sought to restrict public access to drug safety data collected in clinical trials on the basis that it is proprietary information, arguing that competitors could use that information in the development of their own products. However, a number of recent cases of drugs found to have dangerous side effects after coming to market, such as the anti-inflammatory drug rofecoxib (Vioxx), have raised concerns about safety data being treated as confidential.

A new analysis by researchers at the Harvard School of Public Health and Brigham and Women's Hospital of laws and regulations governing public disclosure of clinical trial data submitted to the FDA suggests changes should be made to the way the FDA implements its policy regarding the confidentiality of those data. Allowing greater access to safety data would enable researchers to independently evaluate risks, resulting in more timely risk detection. The review and commentary appears in the current issue of Health Affairs.

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.

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.

Jan. 11 (Bloomberg) -- Barr Pharmaceuticals Inc., the second-largest U.S. maker of generic drugs, is lobbying for a U.S. law that for the first time would routinely allow the sale of copies of medicines made from biotechnology.

"It's what we're eating and breathing," said Jake Hansen, Barr's chief lobbyist in Washington. The company is dispatching about a dozen representatives to press Congress for the law, along with lobbyists from other generic-drug makers. "It's definitely our main focus."

The biotech industry, which includes companies such as Amgen Inc. and Genentech Inc., is countering with its own lobbying campaign. The biotech drugmakers say making copies of gene-based medications, which are more complex than traditional treatments, could pose health risks.

State government on Jan. 1 stopped covering emergency 30-day supplies of prescription drugs for seniors having difficulty obtaining medications under the new federal Medicare benefit. Before expiring, the program had covered 150 prescriptions per day, according to its supporters.

The state-sponsored Medicare Party D Safety Net program was enacted by the Legislature and signed by former governor Mitt Romney in December 2005 and lapsed on Dec. 31, 2006, after the House and Senate could not agree on an extension -- the Senate favored one, but it was dropped by the House in deliberations on an unrelated bill.

According to Health Care For All, an advocacy group that is pushing for the benefit's restoration, individuals are walking away from pharmacy counters without prescribed medications because they can't afford to pay for them.

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.

Pfizer Inc., Amgen Inc. and the rest of the U.S. pharmaceutical industry awoke to a new reality this week: a Congress controlled by Democrats determined to impose costly restrictions on their business.

Five committees are planning investigations into how to lower prices paid by Medicare, improve drug-safety enforcement and make generic medications available faster. Further probes and policy salvos may follow.

The pharmaceutical firms depend on a friendly federal government: A sixth of 2006 growth in the $252 billion U.S. drug market came from Medicare, according to estimates from IMS Health Inc., a Fairfield, Conn.-based research firm. Moreover, both Democrats and the companies are well aware that the industry gave at least two-thirds of its political donations to Republicans in recent elections.

By CHRISTOPHER LEE, The Washington Post

WASHINGTON - Healthcare is to return to the national political stage in 2007, setting up partisan clashes in Congress that could end with rare vetoes from President Bush and help define the 2008 presidential campaigns.

Here is a look at parts of the healthcare agenda in the new Congress:

Medicare prescription drug price negotiations. Proponents, mainly Democrats, say repealing a provision in the 2003 Medicare drug benefit law and forcing the Bush administration to negotiate with drug companies over prices could save billions of dollars a year.

After six years of a steady trade wind of Republican influence, the climate on Capitol Hill has suddenly shifted. For an industry like biotech, which always has a finger in the air to see what's blowing their way, there is reason for both comfort and concern. Comfort comes from seeing a majority of voters around the country clearly backing stem cell research, electing federal and state officials who are opting for science over fundamentalism.

Soon enough the Democrats now in control of the House and Senate are going to put President Bush's veto of the recent stem cell bill to the test and see if they now have the votes to push through new federal funds for the field. They might pull it off, but it will be tough. President Bush has made it clear that he isn't budging on this one inch, leaving a dwindling number of Republicans willing to defend a position that has grown clearly out of favor with the electorate. The concern is justified, too. Democrats are making drug costs an issue again, vowing to do everything they can to lower the bill.

WASHINGTON, Dec. 22 (UPI) -- U.S. congressional leaders want to push for major changes in Medicare Part D, but most voters favor the new prescription-drug program, a survey finds.

Concern about prescription drugs ranked well down the list of "most important" issues listed by voters in exit polls on Election Day, there are overwhelming majorities of seniors happy with the program, and many say they were likely to support officials who voted to create it, according to Democratic pollster Douglas Schoen of Penn, Schoen & Berland Associates.

Only 2 percent of voters polled for each survey said it was the most important factor in their voting decision.

A bipartisan congressional group plans to re-introduce a bill that would allow U.S. residents to import drugs approved by the Food and Drug Administration.

Senators Byron Dorgan, D-N.D., and Olympia Snowe, R-Maine, and Representatives Rahm Emanuel, D-Ill., and Jo Ann Emerson, R-Mo., say passage of the Pharmaceutical Market Access and Drug Safety Act would cut the cost of prescription drugs.

"It is unbelievable that Americans are forced to pay the highest prices in the world for prescription drugs," Dorgan said. "It's time we took some action to put downward pressure on these prescription drug prices, and I think we have a bipartisan group that is going to stand up and move this issue forward."

© 2006 UPI

By David Gratzer

With health-care costs rising year after year — and drug costs rising faster than any other aspect of health spending — Americans wonder how to make drugs cheaper and more accessible. Politicians are listening: During the campaign, for example, Democrats promised seniors a better deal on drugs. But rather than embracing measures that could undermine the innovation of the industry, Congress can quickly and easily reduce the cost of drugs: Return the FDA back to its original mandate.

How much will that medicine cost? It’s a question patients ask me every single day. We love prescription drugs, but bemoan the price of pharmaceuticals. It’s no wonder that Speaker-Designate Nancy Pelosi promises that Washington will “negotiate” drug prices for Medicare, and that she has flirted with reimportation. Not long ago, I might have favored these ideas too — it’s tempting, after all, to think Congress can offer American pharmaceuticals at, say, Canadian prices. But Congressional meddling in the price of drugs would end up destroying the innovation and capital needed to develop new pharmaceuticals, leaving us with Canadian prices and Canadian innovation (or the lack thereof).

WASHINGTON -- Biotechnology lobbyists attempting to slow the development of cheap generic versions of the world's most expensive drugs have been emphasizing questions about their safety in an effort to win support among the new Democratic leaders of Congress.

James C. Greenwood , a former congressman who is president of the Biotechnology Industry Organization , began raising qualms about drug safety with former colleagues on Capitol Hill even as the lawmakers were enlisting cosponsors for legislation to create a speedy mechanism for so-called biogenerics to reach the market.

"We think safety needs to be the primary concern. We think that in order to assure safety, you have to bring a full complement of data with the follow-on product," Greenwood told the Globe in a recent interview.

Oregon Senator Ron Wyden is introducing a new proposal to provide affordable, high quality, private health coverage for everyone regardless of where they work or live with the Healthy Americans Act.

"The Healthy Americans Act provides a guarantee -- health coverage for every American that is at least as good as Members of Congress receive and can never be taken away," Wyden explained. "The Act provides universal coverage for no more money than our country spends today. Better care, financial health and security, no increase in costs."

by Lois M. Collins

Plans for the nation's first large-scale, long-term study of children are proceeding along two paths: The first involves getting ready to hit the pavement and start enrolling families by at least 2008; the other would fold up shop.

The future of the highly publicized National Children's Study, created by Congress in 2000, is at a crossroads. The president's 2007 budget proposal not only didn't fund the study but actually directed it to be closed down. Congress responded with strong language from both the House and Senate indicating avid support for the study. But Congress hasn't actually committed a penny yet in future funding.

"They've implied provision (for the study) but didn't say what that will be," said NCS director Dr. Peter Scheidt. "So we've responded by preparing to do both."

Dec. 7, 2006 - The U.S. Senate voted 80-11 Thursday to back President' Bush's pick to lead the FDA.

The Senate's approval came after months of protests from Republicans and Democrats that blocked Andrew von Eschenbach, MD, from taking the politically sensitive office.

The agency has been without a permanent chief for nearly four and a half of the last six years. During that time the FDA has faced a range of perceived missteps that have increased lawmakers' appetite to reform the agency next year.

The Food and Drug Administration celebrated its first century in 2006, but as 2007 begins, it is also stepping into the cross-hairs of a new Democratic Congress. Bolstered by a public that seems increasingly worried about the FDA's ability to protect it, the Congress is eager to leave its mark on the agency. "There is a confluence of legislation in the coming year," says Scott Gottlieb, deputy FDA commissioner for medical and scientific affairs. "There are some big, must-pass bills, and that will create an environment where a lot of people will be proposing a lot of different ideas."

Key among the FDA reform bills will be legislation by Senators Chuck Grassley (R-Iowa) and Chris Dodd (D-Conn.) to give additional resources to the FDA's drug safety office and make it structurally independent of the agency's drug-approval division. This would remove conflicts of interest, a problem identified in several government studies but which the FDA denies exists. The Grassley-Dodd bill (S 930) also would give the agency more teeth to demand that manufacturers conduct postmarketing surveillance and other measures to track safety issues of newly approved drugs.

CHICAGO (Reuters) - Private insurers in the Medicare insurance program were paid 12.4 percent more by the government than the health care provided would have cost under traditional Medicare, a report released on Thursday said.

Payments to private insurers were $922 more per enrollee in 2005 than they would have been to the government-run program, the report by the nonprofit research group the Commonwealth Fund said.

Private managed-care companies have taken a bigger role in Medicare, the health insurance program for 43 million elderly, after recent changes pushed by President George W. Bush and the Republican-led U.S. Congress.