Roll Call: Latest News on Capitol Hill, Congress, Politics and Elections
December 19, 2014

Posts in "Pharmaceuticals"

December 18, 2014

FDA Looks to Eliminate Some Drug Label Papers

Prescription drug packages include not only medicine but also an array of folded printed instructions and warning notices, all of which are tightly regulated by the Food and Drug Administration. However, the drug regulatory agency wants to eliminate some of the dense reading material. In a rule proposal set for publication on Thursday, the FDA proposes eliminating drug-labeling information provided for those who prescribe the drug, such as physicians and pharmacists. Printed label instructions designed for consumers are not the subject of the rule proposal.

The proposal is not primarily focused on reducing the volume of drug inserts but to make sure the drug prescriber has access to the most current information on the drug. A printed sheet of information is likely immediately out-of-date and health care professionals are urged to seek electronic files on prescribing information. The proposal suggests that the drug label should note directions on finding the electronic label information and acknowledges some disadvantages cited in a 2013 Government Accountability Office report on the use of electronic drug labels.

The FDA estimates drug industry savings of $52-164 million by eliminating the labels or inserts and added pharmacy costs of $47-89 million.


By Paul Jenks Posted at 12:55 p.m.

Senate Committee Offers to Help Fight Prescription Drug Abuse

A reported epidemic of abuse of prescription drugs, which is largely focused on the misuse of prescription painkillers, will continue to focus the attention of the Senate Health, Education, Labor and Pensions Committee next year. Concern about the issue is one topic that enjoys broad bipartisan support within the committee but the panel is short on new ideas for legislative action.

Instead, the bulk of the members of committee on Wednesday wrote to the Department of Health and Human Services, the American Medical Association and groups representing state and local health departments, encouraging continued efforts to stem prescription drug abuse and urged them to tell the committee of any necessary legislative requirements.


November 21, 2014

Rule Updates Clinical Trial Data Disclosure; Watchdog Group Questions NIH Role in Research Protection Update

The Department of Health and Human Services today published a notice of proposed rules on reporting requirements for clinical trials on new drug products. The rules clarify requirements on posting clinical trial results on the federal website – The site contains information on more than 178,000 clinical trials and seeks to prevent duplication of trials and can quickly signal concerns about unsafe or ineffective drugs.

The website is a joint project of the Food and Drug Administration and the National Institutes of Health. However, a public watchdog group this week questioned continuing role of the NIH in the development broader looming rules on human medical research protections. The group, Public Citizen, claims that NIH is the largest federal sponsor and conductor medical research on human subjects and involvement in rule revisions poses a conflict of interest.

November 14, 2014

Big Pharma Swap Meet

Pharmaceutical companies usually do not naturally grow into giant conglomerates all by themselves. The Economist magazine this week explains the unique way most drug manufactures grow: by merging and swapping. The world biggest drug companies are the product of a series of mergers. The drug development cycle is long and risky and drug companies are always varying and adjusting the mix of products to remain profitable. Lately, companies have taken to swapping products with other manufactures in order to concentrate on specific types of drug products.


November 4, 2014

Report Touts Savings from Biosimilar Drugs

The Food and Drug Administration is currently mulling the approval process for drugs that are similar to developed biologic drugs. However, the process is complex. Biologic drugs, unlike traditional chemical drugs — such as aspirin — are derived from living cells, which poses difficulties in replicating and reviewing an alternative version of the drug. The copy of the biologic drug is normally dubbed a ‘biosimilar’.

The drug manufacturer, Novartis AG, which may be the first firm to win U.S. approval of a copycat biotechnology drug, paid the RAND Corp. to look at potential domestic savings from the medicines. The RAND study, which was released on Monday, found that the introduction of biosimilar drugs would reduce direct spending on biologics in the U.S. by $44.2 billion from 2014 to 2024.

CQ HealthBeat’s (@CQHealthTweet) Kerry Young reported (subscription) on Monday that FDA is still reviewing comments on the biosimilar drug regulatory process. Separately, a guest opinion in Roll Call on Monday from Marcia Boyle, the chief of an immunodeficiency disease patient group, urged the FDA to carefully consider patient safety concerns since “even a minor difference between a biosimilar drug and the original biologic product, known as its innovator biologic, could have a significant adverse health impact for a patient.”




FDA Wants Patient Input in Drug and Device Approvals

In 2012, Congress passed and the president signed legislation renewing and adjusting the authority of the Food and Drug Administration to manage the approval process for new drugs and medical devices. The initial bill was crafted in discussions between the FDA and representatives of drug and device manufacturers. Lawmakers included in the final version of the bill a requirement that the FDA include the viewpoints of patients in the regulatory process for approving new drugs and devices.

The FDA, in a notice published today, has opened up a channel for public feedback on how the agency should include patient input. A critical element of the regulatory process involves the weighing of the risks and benefits of a new drug or device and the potential patient viewpoint could spur a decision to accept or reject possible risks. The agency is planning a series of public meetings on the matter but also encourages public feedback.



October 29, 2014

FDA’s Handling of `Pink Viagra’ Not a Gender Issue, Researchers Say

The Food and Drug Administration has been falsely accused of playing gender politics when it comes to the quest for a so-called “pink Viagra,” or a drug to treat lack of sexual desire in women, when the real issue is a lack of proof that a pharmacological approach would work, researchers say.

At issue is the EventheScore campaign, which has drawn more than 24,000 supporters to sign a petition that states: “Do you believe that women deserve equal treatment when it comes to sex? So do we!” This advocacy campaign cites “gender inequity” as a reason why there are  “26 FDA-approved treatments marketed for male sexual dysfunction,” but none for women. That tally counts several forms of male hormone replacement drug testosterone as different drugs. It also includes Pfizer Inc.’s Viagra and four drugs that use the same approach for treating a problem with blood flow that can prevent men from acting on their sexual desires.

Figuring out what causes a lack of sexual desire in women, though, is much trickier than addressing this physiological issue, said Alan Cassels, a drug policy researcher affiliated with the University of Victoria. “Viagra for men is about treating a plumbing problem,” while the cause of diminished sexual desire in women is often unclear and may relate to other issues in their lives, said Cassels, who also is an author of several books critical of the drug industry and a critic of the EventheScore campaign.

In comments made to the FDA ahead of an Oct. 27-28 workshop on female sexual dysfunction, several researchers argued that the EventheScore campaign is co-opting feminist rhetoric with an aim of getting the agency to lower its standards for drug approval. Sprout Pharmaceuticals Inc,, which provides money for the EventheScore campaign, has been struggling to win FDA approval of flibanserin for hypoactive sexual desire in women. This pill is intended to work in the same way as many approved antidepressants, altering the function of certain messengers in the brain known as neurotransmitters.

A better approach would be “finding a pill that will help couples talk to each other, take care of the children, and reduce the stress of modern busy lives,”  said Carol Tavris, a psychologist and author in a comment on the FDA’s workshop plan.


By Kerry Young Posted at 2:46 p.m.

October 21, 2014

DEA Clarifies Drug Wastage Disposal Rules

The Drug Enforcement Administration last month issued final regulations on the disposal of strictly controlled substances, such as prescription painkillers. The regulatory effort hopes to improve and expand on methods of disposing highly regulated substance and adjusts stringent record keeping requirements. The complex rules and record keeping requirements also seek to strictly control the custody of controlled substances. However, hospital groups complained that the new rules were unclear on accounting for unused portions — or drug wastage — from medicine administered to patients and is left over in syringes and IV solutions.

The DEA, in a memo released on Friday, clarified that the regulations do not consider any remaining leftover products used for patients in the hospital as part of the hospital’s drug inventory and subject to provisions of the new regulations.  The rules were designed to assist in collecting unused drugs in patients’ home medicine cabinets but the DEA did not intend for the disposal regulations to apply to hospital drug wastage.  However, the agency does urge hospitals to be careful and document the destruction of the drugs.

October 6, 2014

Reports Examine High Costs of Cancer Drugs and Identify New Carcinogens

Improvements and advances in cancer drugs have allowed cancer patients to begin cycles of home-based drug treatments that previously would have required intensive hospital care. However, a CBS Sixty Minutes report on Sunday explored the extremely high cost of the new cancer drugs. The report questioned researchers that cost of the drugs seems have become almost like another side effect from the cancer.

Meanwhile, the Department of Health and Human Services continues to identify environmental causes of cancer. The department today formally issues a report noting additions to the registry of cancer causing substances in the thirteenth annual report on carcinogens. The newly identified carcinogens include a substances used in cleaning solvents, fuels, tobacco smoke and telephone pole wood preservatives.








By Paul Jenks Posted at 3:34 p.m.

September 29, 2014

Payment Database Set to Document Physician Financial Relationships

Details emerge this week on the murky world financial relationships between physicians and drug manufacturers. The Department of Health and Human Services on Sept. 30 is slated to open access for the general public to a searchable database of payments to physicians and hospitals from the medical industry for research, consulting, meals, travel and other gifts. The 2010 health care overhaul law authorized the public database.

HHS notes that the disclosure of payments from health companies is not intended to signify an inappropriate relationship and that the law does nothing to prohibit such transactions. The relationships could contribute to the design and delivery of life-saving drugs and devices but also could influence physician health care treatment decisions.

CQ HealthBeat’s Kerry Young (@CQHealthTweet) reported last month that the American Medical Association sought to delay the release of the database. The doctors group noted that the registration process is cumbersome and the time required to review the information for accuracy should push the release into next year.


September 18, 2014

Friday Hearing Focuses on Antibiotic Resistance

One of the last events in Congress prior to lawmakers leaving for an election period recess break is a Friday morning House Energy and Commerce subcommittee meeting on the impact of the widespread use of antibiotics, featuring testimony from FDA drug development chief Janet Woodcock.  The liberal use of antibiotics in humans reportedly is causing bacteria to develop resistance to current antibiotic drugs and the House panel will mull efforts to spur development of new drugs.  Meanwhile, the White House this afternoon will announce new executive actions to combat antibiotic-resistant bacteria.

Separately, New York Democratic Rep. Louise M. Slaughter is pressing for the committee to also focus on health impact of animal antibiotic use and notes that antibiotic use in animals also contributes to increasing human antibiotic resistance.  Slaughter, who is spearheading a drive for legislation to force the Food and Drug Administration to monitor the issue, cites a recent Reuters report on agricultural uses of the drugs.  Earlier this month, Perdue Farms, a giant poultry processor,  announced that it has eliminated the use of antibiotics from its chicken hatcheries.



August 1, 2014

Drug Coverage Premiums and Spending Forecast Remain Low

The Department of Health and Human Services  has announced a slight increase in the Medicare Part D program’s premiums for next year. The prescription drug benefit, first implemented in 2006, now offers drug coverage to 39 million people.

Full story

July 29, 2014

Drug Naming Process Gets New Scrutiny From FDA

488548259 web 445x296 Drug Naming Process Gets New Scrutiny From FDA

(Oli Scarff/Getty Images)

The Food and Drug Administration on Monday issued a notice seeking comments on the process of naming prescription drugs, particularly drug manufacturers’ desire to reserve a specific name for a drug product.

Full story

By Paul Jenks Posted at 10:30 a.m.

July 23, 2014

FDA Chief In India Departs

CQ HealthBeat’s Kerry Young reports on the departure of the Food and Drug Administration’s India office chief, Altaf Lal.

Full story

July 15, 2014

Innovation: Fred Upton’s Committee Pushes for Ideas; Report Looks to 2025

The House Energy and Commerce Committee, led by Rep. Fred Upton, R-Mich., over the past few months has been busy examining a range of topics to assist in the development of new legislation to overhaul federal health programs to foster the development of new technologies and medical breakthroughs. The committee is in the process of examining the development and approval process for new drugs and devices. The effort continues later this week with a hearing on leveraging communications technologies.

Full story

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