Prescription Drugs

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GAO Investigation Reveals Gaps in FDA Drug Reviews for Seniors

Rep. Henry A. Waxman and Sen. Edward M. Kennedy today released a new GAO report on FDA’s inclusion of seniors in clinical drug trials for prescription drugs. The report finds that in several key areas, FDA rules for drug approval fail to guarantee the safety and effectiveness of drugs for seniors.

Private Medicare Drug Plans: Seniors and Taxpayers Hurt by High Expenses, Low Rebates

A new report on the Medicare Part D program reveals that the high administrative costs of the private Part D insurers, combined with their inability to negotiate significant drug savings, will cost taxpayers and seniors $15 billion in 2007.

Hearing on FDA’s Role in Evaluating Safety of Avandia

On June 6, 2007, the Committee held an oversight hearing on the role of the Food and Drug Administration in evaluating the safety of Avandia, a diabetes drug taken by about one million Americans. At the hearing, the Committee examined the failure of FDA to obtain an adequate post-market clinical trial designed to assess whether patients taking Avandia are at increased risk of heart attack.

Hearing Examines Safe and Affordable Generic Biotech Drugs

On Monday, March 26, the Oversight Committee held a hearing to examine the high cost of biotech medicines to our health care system, as well the prospects and need for a pathway that would allow the FDA to approve safe and affordable generic versions of biotech drugs. Witnesses included representatives of FDA, pharmaceutical manufacturers, scientists, and consumer groups.

Chairman Waxman Requests Research and Marketing Information from Pharmaceutical and Medical Device Companies

As part of the Committee’s oversight of the marketing practices of the pharmaceutical and device industry, Chairman Waxman sent letters (1) to Eli Lilly and AstraZeneca Pharmaceuticals requesting information related to Zyprexa (olanzapine) and Seroquel (quetiapine), drugs used to treat bipolar disease and schizophrenia; (2) to Boston Scientific Corporation and the Cordis Corporation requesting information on the companies’ drug coated stents; and (3) to Cephalon regarding Actiq, a powerful narcotic lollipop, and Fentora, a narcotic lozenge, both approved to treat pain associated with cancer.

Chairman Waxman Requests that Novartis Reassess Stance on Patent Law in India

Chairman Waxman writes to Novartis CEO Dr. Daniel Vasella expressing concern that because of India’s key role in producing medicines for the developing world, the company’s challenge of public health safeguards in India’s patent law may impact worldwide access to medicine.

Chairman Waxman Requests Information on Medicare Part D Prescription Drug Program

Chairman Waxman sent a letter to the chief executives of twelve Medicare insurers requesting Part D prescription drug pricing information, including profits and administrative costs associated with Medicare Part D coverage.

Financial Impacts of Waste, Fraud, and Abuse in Pharmaceutical Pricing

The goal of the hearing is to examine whether there are fraudulent, abusive, or wasteful pharmaceutical pricing practices that affect federal health programs such as Medicaid, Medicare, and the Public Health Service “340B” program that should be the subject of additional congressional oversight.

GAO Analysis Refutes Industry Myths About Drug Development

Rep. Waxman, along with Sens. Durbin and Kennedy, today released a new GAO analysis revealing a decline in new drug development by the pharmaceutical industry. The report contradicts the myth that higher research expenditures have resulted in more treatment options for patients.

Based on Claritin-D Advertisement, Rep. Waxman Renews Request That FDA Investigate Phenylephrine Oral Nasal Decongestants

Citing a new Claritin-D advertisement, Rep. Waxman renews his request that the FDA investigate whether phenylephrine oral nasal decongestants are effective. In the ad, Schering-Plough announced that it will not reformulate Claritin-D, a pseudoephedrine-based oral nasal decongestant, to switch to phenylephrine.

Drug Company Profits Soar Under Medicare Drug Plan

Today the Democratic Truth Squad released a new analysis that reveals pharmaceutical industry profits increased by over $8 billion in the first six months after the Medicare drug plan went into effect.

Rep. Waxman Requests Investigation of Effectiveness of Phenylephrine Nasal Decongestants

Rep. Waxman asks FDA to investigate whether phenylephrine oral nasal decongestants are effective. Manufacturers have begun to offer alternatives that eliminate pseudoephedrine and rely instead on phenylephrine, which permits them to be sold over-the-counter without any restrictions. Medical studies indicate that phenylephrine may be no more effective than placebo in alleviating nasal congestion, raising questions regarding FDA’s conclusion that the drug is safe and effective for over-the-counter use.

GAO Finds Medicare Drug Plans Fail to Accurately Answer Consumer Questions

A new GAO report finds that call centers run by private Medicare drug plans provide inaccurate and incomplete information to consumers. GAO found that in most instances, prescription plan providers were unable to accurately respond to simple questions about plan costs, low-income coverage, plan formulary procedures, and plan utilization management techniques.

Prescription for Harm: The Decline in FDA Enforcement Activity

A new report by Rep. Henry A. Waxman examines how the Bush Administration has carried out FDA’s historic enforcement responsibilities. The report is the result of a 15-month investigation that included a review of thousands of pages of internal agency enforcement records. It finds that there has been a precipitous drop in FDA enforcement actions over the last five years.

Dramatic Rise in Collusion Between Pharma and Generic Drug Companies is Hiking Prices

Sen. Schumer and Rep. Waxman write to the heads of the two major pharmaceutical trade organizations asking them to take a strong, public stance against the recent dramatic rise in settlements where pharmaceutical companies pay off generic drug companies to keep cheaper generics off the market.

Democrats Call on Bush Administration to Withdraw Drug Liability Rule

Today Reps. Waxman, Dingell, and Brown sent a letter to Secretary Leavitt objecting to FDA’s claim that state lawsuits related to prescription drugs should be barred by FDA regulation of prescription drugs and pointing out that FDA justifies this claim with misleading statements and critical omissions. Sens. Kennedy and Dodd also also sent a letter to Secretary of Health and Human Services Leavitt urging him to withdraw language in a Food and Drug Administration drug labeling regulation that says FDA regulation of prescription drugs bars lawsuits against drug manufacturers and doctors, and questioning the justification for barring such lawsuits.

Rep. Waxman Asks GAO to Examine Accuracy, Utility of Medicare Drug Benefit Information

Reps. Waxman, Rangel, Dingell, Stark, and Sherrod Brown ask GAO to investigate whether information that seniors are now receiving from CMS and from private drug plans about the Medicare drug benefit is helpful and accurate.

CAFTA Hinders Developing Nations' Access to Needed Medicines

Rep. Waxman releases a report detailing how CAFTA and other Bush Administration trade agreements are impeding the rights of developing nations to acquire essential medicines at affordable prices.

Administration Urged Not to Interfere With Essential Medicines List

Rep. Waxman writes to HHS Secretary Michael O. Leavitt about reports that the Bush Administration is seeking to keep drugs used for safe and legal medical abortions off of the World Health Organization's list of essential drugs for developing countries. A scientific panel recently concluded that expanded access to these drugs could reduce the annual toll of 68,000 maternal deaths from unsafe abortions.

Merck Documents Show Aggressive Marketing of Vioxx After Studies Indicated Risk

Rep. Waxman releases an analysis of over 20,000 pages of documents that suggests that Merck sent more than 3,000 highly trained representatives into doctor's offices and hospitals armed with misleading information about Vioxx's risks.

FDA Enforcement Efforts Decline

There has been a sharp decline in FDA enforcement actions against misleading drug advertisements and violations of manufacturing standards by biologic drug companies since Dr. Lestor Crawford was appointed as Acting Commissioner in early 2002.

GAO Asked to Investigate Prescription Drug Card Program

Rep. Waxman asks GAO to investigate aspects of the prescription drug discount card program established under the new Medicare law, including the selection of sponsoring organizations and the value of the cards for beneficiaries.

New Medicare Rules May Increase Risk from Unregulated Compounded Drug Copies

Rep. Waxman asks HHS to revise the proposed Medicare rule that would allow the use of pharmacist-made copies of brand-name prescription drugs to ensure that seniors are not exposed to the serious health risks posed by these non-FDA approved drugs.

Medicare Drug Card Website Rife with Errors

Reps. Waxman and Slaughter reveal that the pharmacy information on the Medicare.gov web contains multiple errors, incorrectly identifying the Medicare drug cards that can be used at many pharmacies.

Prescription Drug Cards Still Provide Few Discounts to Seniors

An analysis released by Rep. Waxman finds that the Administration’s claims that competition would reduce drug prices under the new Medicare discount cards have yet to materialize.

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