Some Medicines and Driving Don’t Mix

Some Medicines and Driving Don’t Mix

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a wet road with oncoming cars on a rainy day seen through car windshield with combined images of medicine and an ambulance in the rear view mirror

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If you’re taking a medication, is it safe to drive?

Most likely, yes. Still, the U.S. Food and Drug Administration (FDA) advises you to make sure before operating any type of vehicle, whether a car, bus, train, plane, or boat.

Although most medications won’t affect your ability to drive, some prescription and over-the-counter (OTC) drugs (also called nonprescription medicines) can have side effects and cause reactions that may make it unsafe to drive, including:

  • sleepiness/drowsiness
  • blurred vision
  • dizziness
  • slowed movement
  • fainting
  • inability to focus or pay attention
  • nausea
  • excitability

Some medicines can affect your driving for a short time after you take them. For others, the effects can last for several hours, and even the next day. And some medicines have a warning to not operate heavy machinery — this includes driving a car.

Medicines That Might Affect Driving

Knowing how your medications — or any combination of them — affect your ability to drive is a safety measure. Some drugs that could make it dangerous to drive include:

  • opioid pain relievers
  • prescription drugs for anxiety (for example, benzodiazepines)
  • anti-seizure drugs (antiepileptic drugs)
  • antipsychotic drugs
  • some antidepressants
  • products containing codeine
  • some cold remedies and allergy products, such as antihistamines (both prescription and OTC)
  • sleeping pills
  • muscle relaxants
  • medicines that treat or control symptoms of diarrhea
  • medicines that treat or prevent symptoms of motion sickness
  • diet pills, “stay awake” drugs, and other medications with stimulants (e.g., caffeine, ephedrine, pseudoephedrine)

Also, avoid combining medication and alcohol while driving.

Some Sleep Medicines Can Impair You, Even the Next Morning

People with insomnia have trouble falling or staying asleep. Many take medicines to help sleep. Come morning, though, some sleep medicines could make you less able to perform activities for which you must be fully alert, including driving.

A common ingredient in a widely prescribed sleep medication is zolpidem, which belongs to a class of medications called sedative-hypnotics. The FDA has found that medicines containing zolpidem, especially extended release forms, can impair driving ability and other activities the next morning.

Zolpidem immediate and extended-release forms are marketed as generic drugs and under these brand names:

  • Ambien and Ambien CR (oral tablet)
  • Edluar (tablet placed under the tongue)
  • Intermezzo (tablet placed under the tongue)
  • Zolpimist (oral spray)

People who take sleep medicines should talk to their health care professional about ways to take the lowest effective dose. Don’t assume that non-prescription sleep medicines are necessarily safer alternatives. The FDA is also evaluating the risk of next-day impairment with other insomnia drugs, both prescription and OTC versions.

Allergy Medicines Can Affect Your Ability to Drive

For allergy sufferers, medications containing antihistamines can help relieve many different types of allergies, including hay fever. But these medicines may interfere with driving and operating heavy machinery (including driving a car). Antihistamines can slow your reaction time, make it hard to focus or think clearly, and may cause mild confusion even if you don’t feel drowsy.

Read the OTC Drug Facts label of your medicine and understand the warnings before using it. Also, avoid drinking alcohol or taking sleep medications while using some antihistamines. Those combinations can increase the sedative effects of antihistamines.

How to Avoid Driving Impaired

You can still drive safely while taking most medications. Talk to your health care provider about possible side effects. For example, some antihistamines and sleep medications work for longer periods than others. You might feel the sedating effects of these medications for some time after you’ve taken them, and maybe even into the next day.

Doctors and pharmacists can tell you about known side effects of medications, including those that interfere with driving. You can also request printed information about the side effects of any new medicine.

To manage or minimize side effects while driving, your health care provider may be able to adjust your dose, adjust the timing of when you take the medicine, or change the medicine to one that causes fewer side effects for you.

Here are some more tips:

  • Always follow directions for use and read warnings on medication packaging, or handouts provided by the pharmacy.
  • Don’t stop using your medicine unless your prescriber tells you to.
  • Tell your health care provider about all the products you are taking, including prescription, OTC, and herbal products. Also, let them know about any reactions you experience.

http://www.fda.gov/consumers/consumer-updates/some-medicines-and-driving-dont-mix

Future Of Key Farming Research Uncertain As 2/3 Of USDA Staff Say They Won’t Move

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Secretary of Agriculture Sonny Perdue, shown here on Capitol Hill in April, announced last month that most staff from two USDA research agencies were being relocated to the Kansas City region. J. Scott Applewhite/AP hide caption

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J. Scott Applewhite/AP

Secretary of Agriculture Sonny Perdue, shown here on Capitol Hill in April, announced last month that most staff from two USDA research agencies were being relocated to the Kansas City region.

J. Scott Applewhite/AP

Two vital research agencies at the U.S. Department of Agriculture are hemorrhaging staff as less than two-thirds of the researchers asked to relocate from Washington, D.C. to the Kansas City area have agreed to do so.

When U.S. Secretary of Agriculture Sonny Perdue announced the planned new location of the research agencies last month, he said it “will be placing important USDA resources closer to many stakeholders” and “increasing the probability of attracting highly-qualified staff with training and interests in agriculture.”

But groups such as the Union of Concerned Scientists call it a “blatant attack on science” that will “especially hurt farmers, ranchers and eaters at a particularly vulnerable time.”

The American Federation of Government Employees, the union representing the USDA’s Economic Research Service and the National Institute of Food and Agriculture, said the relocation “has resulted in catastrophic attrition at USDA’s top research agencies.”

“Evidence suggests that the relocation of these agencies is an attempt to hollow out and dismantle USDA science that helps farmers and protects our food supply,” the union added.

The USDA gave employees until just before midnight on Monday to notify their employers whether they planned to accept the relocation.

On Tuesday, a USDA spokesperson told NPR that at ERS, 72 employees accepted relocation and 99 declined or did not respond. At NIFA, the spokesperson says 73 accepted and 151 declined or did not respond. That means the total number that accepted is about 36 percent of those reported.

The USDA spokesperson said that these numbers may fluctuate until Sept. 30, the date employees are expected to report to the area, and employees can change their statuses until then.

They added that the USDA is working “to ensure separating employees have the resources they need as well as efforts to implement an aggressive hiring strategy to maintain the continuity of ERS and NIFA’s work.”

Last month, the USDA said that of the 644 jobs in the two agencies, 544 would be relocated and 100 would remain in the D.C. area. The numbers reported on Tuesday by the USDA do not appear to account for some 150 positions that the USDA initially announced would be relocated.

The department did not immediately respond to explain the difference, though the employees’ union has reported high rates of “retirements, employees securing new jobs, and employees choosing to be terminated.” A statement last month from three Democratic senators said that ERS had a vacancy rate of 20% and NIFA had a vacancy rate of 26.4%.

NIFA provides grants for research on agriculture-related science, and the ERS conducts research and analysis on topics such as outlooks on major crops and livestock, how much food is going to cost, and whether U.S. households will be food secure.

It’s not yet clear whether the research agencies will be located in Kansas or Missouri, according to The Kansas City Star.

Lawmakers from both states, including Kansas Sen. Jerry Moran, have supported the move. “My first thought was Kansas City would be the perfect place,” the Republican said, as NPR’s Frank Morris reported.

An ex-employee of ERS recently told Morris that “efforts by the secretary … have just destroyed morale.” He said the way the agency is run has become increasingly partisan, and he resigned after the surprise announcement about relocations.

“I think it’s had its intended effect. People have left, morale is low. The agency will take a long time to recover from the damage that’s been inflicted,” the former employee told Morris.

Some of ERS’ recent studies, as Morris noted, may be politically uncomfortable for the Trump administration:

Perdue said last month that the move would save the USDA some $300 million. That number has been met with skepticism by some analysts. The Agricultural & Applied Economics Association estimated the relocation would actually cost taxpayers between $83 million and $182 million, partially due to the lost value of the research from staffers who decide not to move.

Provided By NPR

Public Notification: Boss Lion 9000 contains hidden drug ingredient

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[7-16-2019] The Food and Drug Administration is advising consumers not to purchase or use Boss Lion 9000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

Image of Boss Lion

FDA laboratory analysis confirmed that Boss Lion 9000 contains sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for erectile dysfunction. This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

Health care professionals and patients should report adverse events or side effects related to the use of this product to FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Note: This notification is to inform the public of products marketed as dietary supplements or conventional foods with hidden drug ingredients and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories. 

For more information: 

http://www.fda.gov/drugs/medication-health-fraud/public-notification-boss-lion-9000-contains-hidden-drug-ingredient

Health Fraud Scams

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The U.S. FDA issued letters to these companies for illegally marketing products for the treatment or prevention of serious diseases. Thirty days after FDA issued these letters, the companies listed have failed to voluntarily cease illegally marketing products for serious diseases.

The U.S. FDA sent abuse complaints to registrars managing websites that offer any unapproved drugs or uncleared devices, or potentially counterfeit, controlled, adulterated or misbranded products to U.S. consumers in violation of U.S. law.

This list only includes a small fraction of the potentially hazardous products with hidden ingredients marketed to consumers on the internet and in retail establishments. FDA is unable to test and identify all products marketed as dietary supplements on the market that have potentially harmful hidden ingredients.

The page provides information gathered from press announcements and other public notices about certain recalls of health fraud related products regulated by FDA.

http://www.fda.gov/consumers/protecting-yourself/health-fraud-scams

Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards – 07/17/2019 – 07/17/2019

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Organized By:

The Food and Drug Administration (FDA) is re-announcing three public meetings entitled “Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards.” The purpose of these public meetings is to provide the pharmaceutical industry and other interested parties with information on the plans, progress, and technical specifications to upgrade electronic submission standards for the premarket and postmarket safety surveillance programs managed by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). These meetings will focus on enhancements to electronic submission of Individual Case Safety Reports (ICSRs) in FAERS using ICH E2B(R3) standards.

Dates and Times:

March 25, 2019, from 9:00 a.m. – 4:00 p.m. 
July 17, 2019, from 9:00 a.m. – 4:00 p.m.
February 19, 2020, from 9:00 a.m. – 4:00 p.m.

Location:

For March 25, 2019 meeting:
Silver Spring Civic Building at Veterans Plaza
The Buffalo Soldiers Great Hall
One Veterans Place
Silver Spring, MD 20910

*Please enter the building from the Plaza side
GPS Device Address: 8525 Fenton Street, Silver Spring, MD 20910

For July 17, 2019 and February 19, 2020 meetings:
FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31 Conference Center, the Great Room (Rm. 1503, Section A)
Silver Spring, MD 20993-0002

Meeting Materials

July 17, 2019 meeting:

March 25, 2019 meeting:

Registration:

To register for the second public meeting scheduled for July 17, 2019, please visit the following website: https://fdae2br3.eventbrite.com. The deadline for registration has been extended to July 12, 2019, 11:59 p.m. Eastern Time.

Please provide complete contact information for each attendee, including name, title, affiliation, address, email, telephone and method of attendance (in-person or web conference). Registration is free and based on space availability, with priority given to early registrants. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public meeting will be provided beginning at 8:00 a.m.

During online registration you may indicate if you wish to present during the public comment session. All requests to make oral presentations must be received by 11:59 p.m. Eastern Time on June 14, 2019, for the second meeting. Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin and will select and notify participants by 11:59 p.m. Eastern Time on June 26, 2019. Further information will be made available on the Federal Register Notice.

Streaming Webcast and the Video of the Public Meeting:

Each public meeting will be webcast. A video recording of the public meetings will be available at the same website address for 1 year.

The webcast link for the July 17, 2019 meeting is https://collaboration.fda.gov/faers071719/.

If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm.

The webcast links from the March 25, 2019 meeting are available below:

Comments on the Public Meeting:

Please refer to the Federal Register Notice on instructions for submitting either electronic or written comments on this public meeting. We request that comments are submitted before or within 30 days of each public meeting. The deadline for comments for the July 17, 2019 meeting is August 16, 2019.

The deadline for comments for the March 25, 2019 meeting was April 25, 2019. The comment period for that meeting is now closed.

Transcripts:

Monday, March 25, 2019 (PDF – 1MB)

The transcript will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES in the Federal Register Notice). A link to the transcript is also available on the internet at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm115894.htm.

Contact Information:

Email: eprompt@fda.hhs.gov


Event Materials

http://www.fda.gov/drugs/news-events-human-drugs/electronic-submission-adverse-event-reports-fda-adverse-event-reporting-system-faers-using

Accelerating Drug Development for Polyarticular Juvenile Idiopathic Arthritis (pJIA)

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The Divisions of Pulmonary, Allergy, and Rheumatology Products and Pediatric and Maternal Health, in collaboration with the University of Maryland CERSI, is announcing a 1-day public workshop, “Accelerating Drug Development for Polyarticular Juvenile Idiopathic Arthritis (pJIA)”.  The aim of the workshop will be to discuss current barriers to expeditious pJIA drug development and steps to overcome them.  Specific topics will include extrapolation, trial design considerations, dose selection, modeling and simulation, and level of evidence required to establish safety and effectiveness in pediatric patients with pJIA. 

The public workshop will be held on:
Date:  Wednesday, October 2, 2019
Time:  8:00am to 5:00pm

Location:
The public workshop will be held at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Silver Spring, MD 20993-0002. Entrance for the public workshop participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed.  For parking and security information, please refer to Public Meetings at the FDA White Oak Campus.

Registration:  This workshop is open to the public with no cost to attend, but registration is still required.  See M-CERSI Events for registration, agenda and webcast access. 

Special Accommodations: If special accommodations at the workshop are needed due to a disability, please email Ann Anonsen at aanonsen@umd.edu at least seven (7) days in advance of the workshop. Requests for sign language interpretation or Computer Aided Realtime Translation (CART)/captioning should be made two (2) weeks in advance of the workshop, and should be sent directly to the FDA Interpreting Services Staff at interpreting.services@oc.fda.gov 

More Information:  Contact Jacquline Yancy, (301)796-7068; e-mail Jacquline.Yancy@fda.hhs.gov  or
Meshaun Payne, (301) 796-6668; email Meshaun.Payne@fda.hhs.gov

http://www.fda.gov/drugs/news-events-human-drugs/accelerating-drug-development-polyarticular-juvenile-idiopathic-arthritis-pjia

Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Sold at Wal Mart

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Summary

Company Announcement Date:
July 03, 2019
FDA Publish Date:
July 05, 2019
Product Type:
Drugs
Over-the-Counter Drugs
Reason for Announcement:

Recall Reason Description

Potential for nonsterility

Company Name:
Altaire Pharmaceuticals, Inc.
Brand Name:

Brand Name(s)

Equate and Support Harmony

Product Description:

Product Description

Over-the-Counter (OTC) drug products


Company Announcement

Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within expiry, sold at Wal-Mart during the time period as indicated in the tables below. As a precautionary measure, Altaire is initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. This recall is being carried out to the retail level and is only for the specific lots listed above. No other lots are being recalled.

Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. To date, Altaire has received no reports of adverse events, nor has Altaire obtained any out of specifications results including Sterility testing, for the products.

Product Description: Equate Restore Tears Lubricant Eye Drops Twin Pack W-M item #: 552374320 NDC #: 49035-189-49 Package Size: 2 x 15 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
17196 07/19 08/15/2017
17292 09/19 11/03/2017
17355 11/19 12/22/2017
19040 02/21 03/26/2019

Product Description: Equate Eye Allergy Relief Drops W-M item #: 567371432 NDC #: 49035-887-13 Package Size: 15 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
19128 05/21 06/20/2019
19009 01/21 01/28/2019
19003 01/21 02/21/2019
19034 01/21 03/07/2019
19060 02/21 04/22/2019
19061 02/21 05/21/2019
18252 10/20 11/21/2018
18058 03/20 03/22/2018
18224 09/20 09/26/2018
18185 07/20 08/27/2018
18152 06/20 07/05/2018
18159 06/20 07/18/2018
18091 04/20 06/07/2018
18090 04/20 04/27/2018
18069 03/20 04/04/2018

Product Description: Equate Sterile Lubricant Stye Ointment W-M item #: 563031651 NDC #: 49035-875-50 Package Size: 3.5 gram

Lot Number Expiration Date Manufacturer Initial Ship Date
SAJ 01/21 03/23/2018
SFE 06/21 07/05/2018
SIA 09/21 10/23/2018
RIE 09/20 09/28/2017
REH 05/20 07/21/2017
RAD 01/20 05/23/2017
TAH 01/22 02/14/2019
TDD 04/22 05/29/2019

Product Description: Equate Comfort Gel Lubricant Eye Gel Twin Pack W-M item #: 552374319 NDC #: 49035-197-49 Package Size: 2 x 15 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
17384 12/19 01/17/2018
17259 08/19 10/27/2017
19002 01/21 01/22/2019
19041 02/21 04/09/2019
18222 09/20 09/25/2018
18084 04/20 06/15/2018

Product Description: Equate Restore PM Nighttime Lubricant Eye Ointment W-M item #: 551282425 NDC #: 49035-191-50 Package Size: 3.5 gram

Lot Number Expiration Date Manufacturer Initial Ship Date
SKG 08/21 12/18/2018
SHK 08/21 10/09/2018
SHJ 08/21 09/13/2018
SEC 05/21 07/13/2018
SCB 03/21 01/14/2019
SBC 02/21 03/21/2019
RLB 12/20 12/27/2017
RBB 02/20 04/28/2017
RHR 08/20 10/04/2017
RFK 06/20 07/28/2017
RAB 01/20 03/21/2017
TAD 01/22 01/25/2019
TAQ 01/22 03/18/2019
TBI 02/22 04/29/2019
TDB 04/22 06/07/2019
QHE 08/19 09/27/2016
QJD 10/19 12/07/2016
SGE 07/21 08/07/2018

Product Description: Equate Night & Day Restore Tears Lubricant Eye Pack W-M item #: 567368000 NDC #: 49035-883-59 Package Size: 3.5g and 15mL

Lot Number Expiration Date Manufacturer Initial Ship Date
KT19146 02/21 06/05/2019
KT18133 04/20 12/12/2018
KT18194 07/20 01/15/2019
KT18129 02/20 05/25/18

Product Description: Equate Support Advanced Twin Pack W-M item #: 567371433 NDC #: 49035-885-49 Package Size: 2 x 15 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
19137 05/22 06/06/2019
19022 01/22 02/18/2019

Product Description: Equate Support Advanced Lubricating Eye Drops Dose Preservative Free W-M item #: 563031654 NDC # 49035-882-54: Package Size: 25 count (0.6 mL fill):

Lot Number Expiration Date Manufacturer Initial Ship Date
RKP 11/19 01/08/2018
RIN 09/19 12/22/2017
SLC 12/20 01/16/2019
RIF 09/19 10/10/2017
TBE 02/21 03/26/2019
TBI 02/21 05/15/2019
SHB 08/20 10/03/2018

Product Description: Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free W-M item #: 567367998 NDC #: 49035-882-52 Package Size: 7.5 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
19015 01/21 02/06/2019
19117 04/21 05/20/2019
18080 07/20 08/02/2018
18111 05/20 05/25/2018

Product Description: Equate Support Moisture Lubricant Eye Drops W-M item #: 553503238 NDC #: 49035-145-10 Package Size:10 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
19011 01/21 04/01/2019
18052 02/20 03/26/2018
18266 10/20 01/15/2019
18178 07/20 08/20/2018
17385 12/19 01/24/2018

Product Description: Support Harmony Lubricant Eye Drops W-M item #: 553503238 NDC #: 49035-145-10 Package Size: 10 mL (Note: Support Harmony packaging was discontinued in January 2018.)

Lot Number Expiration Date Manufacturer Initial Ship Date
17290 09/19 11/03/2017

The products are manufactured and labeled exclusively for Wal-Mart. Altaire ships the products labeled for Wal-Mart only to Wal-Mart. The products are distributed at the retail level by Wal-Mart. Altaire has also requested that Wal-Mart notify its customers.

Altaire has notified Wal-Mart by e-mail on July 3, 2019 announcing the recalls of the products/lots identified herein, with specific directions for return of all units of the impacted lots.

Customers with questions regarding this recall can contact Altaire Pharmaceuticals Inc., by calling 1-800-258-2471, or e-mailing otcdruggist@aol.com Monday thru Friday from 8:30 a.m. to 5:00 p.m. ET. Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems associated with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Altaire takes its mission of customer safety and providing quality products very seriously. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility.


Company Contact Information

Media:
Michael Sawaya, Joseph Sawaya
1-800-258-2471

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/altaire-pharmaceuticals-inc-issues-voluntary-recall-multiple-ophthalmic-products-sold-wal-mart

Reports: Jeffrey Epstein Arrested On Sex Trafficking Charges

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Jeffrey Epstein, pictured here in an undated photo, was arrested Saturday and charged with sex trafficking, according to media reports. Rick Friedman/Corbis via Getty Images hide caption

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Rick Friedman/Corbis via Getty Images

Jeffrey Epstein, pictured here in an undated photo, was arrested Saturday and charged with sex trafficking, according to media reports.

Rick Friedman/Corbis via Getty Images

The multimillionaire financier and convicted sex offender Jeffrey Epstein was arrested Saturday in the New York area and charged with sex trafficking relating to incidents from the early 2000s, according to multiple media reports citing anonymous law enforcement sources.

NPR has not independently confirmed the reports.

Epstein, 66, is expected to appear in federal court in New York Monday.

Under a controversial plea deal reached in 2007 with Alex Acosta, who was the U.S. attorney in Miami at the time, Epstein pleaded guilty in 2008 to Florida state charges of soliciting prostitution and avoided more serious federal charges relating to allegations of molesting dozens of young girls.

Acosta is now secretary of labor in the Trump administration. A federal judge ruled earlier this year that the plea deal was illegally concealed from Epstein’s alleged victims.

The Miami Herald published an investigation last year of the reported collaboration between federal prosecutors and Epstein’s lawyers.

Epstein “essentially came up with this sex operation where he would recruit girls — underage girls in Palm Beach, have them come to his home for a massage,” Miami Herald reporter Julie Brown told NPR in February. “Ostensibly that’s what they were being asked to do, but he molested them. And authorities suspect that he molested hundreds of girls over a five- or six-year period in Palm Beach alone and possibly operated an international sex-trafficking organization around the world.”

But under the agreement over a decade ago, Epstein avoided serious time behind bars. He served 13 months in county jail and registered as a sex offender. He was granted work release and spent most days at his office in Palm Beach.

U.S. District Judge Kenneth Marra in the Southern District of Florida is now deciding whether that nonprosecution agreement should still stand.

The new charges are in a sealed indictment, according to CBS Miami. They “involve alleged sex trafficking crimes committed between 2002 and 2005, according to law enforcement sources. The indictment alleged that the crimes occurred in both New York and Palm Beach, Florida.”

The station says Epstein is charged with one count of sex trafficking and one count of conspiracy to commit sex trafficking and will appear for a bond hearing Monday.

Provided By NPR

Illinois Governor Signs Law Legalizing Recreational Use Of Marijuana

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Customers buy products at the Harvest Medical Marijuana Dispensary in San Francisco in 2016. Illinois has joined California and nine other states in legalizing the recreational use of the drug. Haven Daley/AP hide caption

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Haven Daley/AP

Customers buy products at the Harvest Medical Marijuana Dispensary in San Francisco in 2016. Illinois has joined California and nine other states in legalizing the recreational use of the drug.

Haven Daley/AP

Illinois has become the 11th state in the country to legalize the recreational use and purchase of marijuana.

Democratic Gov. J.B. Pritzker, who was elected last year, signed the bill into law on Tuesday, fulfilling a key campaign promise. The state joins 10 others and the District of Columbia in allowing recreational use. The legislation takes effect on Jan. 1, 2020.

The new law allows Illinois residents age 21 and older to possess up to 30 grams of cannabis flower, 5 grams of concentrate and 500 milligrams of THC in products such as edibles.

It also will expunge the records of 800,000 people with criminal records as a result of purchasing or possessing 30 grams or less of marijuana. It earmarks a quarter of the tax revenue from the sale of cannabis to redevelop impoverished communities in the state and gives vendor preference to minority owners.

“Legalizing adult-use cannabis brings an important and overdue change to our state, and it’s the right thing to do,” Pritzker said in a statement. “This legislation will clear the cannabis-related records of nonviolent offenders through an efficient combination of automatic expungement, gubernatorial pardon and individual court action.”

Although 10 other states have approved the recreational use of marijuana — Alaska, California, Colorado, Maine, Massachusetts, Michigan, Nevada, Oregon, Vermont and Washington – several others have decriminalized and/or approved cannabis for medical use.

Provided By NPR

FDA-ASCO-Friends Workshop on Development of Tissue-Agnostic, Biomarker-Based Indications

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Co-Sponsored by the:
U.S. Food & Drug Administration (FDA), American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (Friends)
Twitter: #FDATissueAgnostic19

Date:            April 26, 2019

Time:           8:30 am to 4:00 pm

Location:    FDA White Oak Campus

Building 31, Room 1503 – Great Room, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Background:

The FDA, ASCO and Friends are convening this public workshop to identify clinical trial designs and strategies to accelerate drug development based on biomarkers that are agnostic to tissue types. The workshop is intended to explore concepts in research and development that would assist the research community and regulators in understanding how to optimize product development and patient access to safe and effective biomarker-driven therapies that have clinical use across a variety of cancer types.

Workshop Objectives:

  • Seek feedback from industry, academia, patients and other stakeholders on trial designs and analysis approaches that will aid in understanding the effect of a biomarker and its related diagnostic assay across multiple tissue types,
  • Ensure that cancer patient advocates and the leading experts in clinical research, pharmacology, drug manufacturing, and clinical care have an opportunity to contribute to the discussion about how to demonstrate safety and efficacy of a drug across multiple cancer types and how to communicate that information to the clinical community, and
  • Obtain input from multiple stakeholders on approaches the FDA uses to review applications for drug products that are intended to treat cancers based on the presence of a biomarker, rather than specification of the tissue type.

Webcast Information:

FDA provided a free-of-charge, live webcast of this workshop. Recordings of the webcast can be found at the following links:

Meeting Information: 

Contact:

If to ASCO:  
Anna Jinkerson, MScM
Anna.Jinkerson@asco.org
(571) 483-1577

If to FDA:     
Sonia Swayze
Sonia.Swayze@fda.hhs.gov
(301) 796-6132

Dianne Spillman
Dianne.Spillman@fda.hhs.gov
(301) 796-1467

If to Friends
Ryan Hohman, JD
rhohman@focr.org
(202) 944-6708

Mark Stewart, PhD
mstewart@focr.org
(202) 944-6700

http://www.fda.gov/drugs/news-events-human-drugs/fda-asco-friends-workshop-development-tissue-agnostic-biomarker-based-indications

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