The following is a response to the White House Petition submitted on behalf of the Frum 6 year old boy suffering from a severe disease R’L:
What We Have to Say About Your Petition and Expanded Access. Thank you for your petition. The situation faced by the Cohens — and all families facing childhood cancer — is heartbreaking.
As you may know, the Food and Drug Administration (FDA) is responsible for ensuring that drugs and other medical products sold in the United States are safe and effective. Drugs that haven’t yet been approved for marketing are called “investigational new drugs.” When those drugs show promise, the FDA may allow patients to enroll in clinical trials of those drugs or — in cases when joining a trial isn’t possible and there are no comparable or satisfactory treatments — to be able to use those drugs through expanded access.
This is often referred to as “compassionate use,” but it’s not without risk. Since the treatments are still being investigated, it isn’t known if they are safe or effective. Indeed, there’s the risk that the treatment could be not only ineffective, but make a patient’s condition worse.
In cases like Refael Elisha’s, the drug company that produces the treatment in question works together with the patient and, in some cases, with the patient’s doctor, to request approval from the FDA to treat the patient with the investigational drug. The same standards that prevent the White House from interfering with the outcome of an agency’s independent adjudications or research also apply in cases like Refael Elisha’s. The decision whether to allow compassionate use depends on a number of factors, including what the agency knows about the safety and effectiveness of the proposed treatment. The patient his illness, his treating physician, and the drug company are all involved in that decision.
We are confident that FDA will rely on its expertise and scientific judgment as it evaluates Refael Elisha’s case.
The FDA provides a variety of resources should you want to learn more about compassionate use or want to request approval from FDA:
• Access to Investigational Drugs Outside of a Clinical Trial (Expanded Access)
• Investigational New Drug (IND) Application
You may also contact the FDA’s Office of Health and Constituent Affairs for information and assistance.
Tell us what you think of this petition response and We the People.
This whole petition the White House business is baloney, they never do anything about the petition they just give a political drasha why they are not going to do anything to help the cause.
what does this all mean in plain simple english??
To number one. That is not true. Start a petition to legalize marijuana.
In short, they said its up to the FDA.
Why anyone thought the White House would give a different response is beyond understanding. The FDA is an independent, scientific body and the White House would never allow itself to be seen as influencing FDA decisions. People have to use logic…
Exactly why I never wasted my time signing this petition. I knew its going nowhere. People that encourage this petition should know better.
Even if it went no where, it still gives the family chizuk to know that so many people in klal yisroel care about them and support them in all they’re going through. May Hashem grant Refoel Elisha a Refua Sheleima Bikarov.
This child has not been given any other medical opportunities at this time. Why shouldn’t Washington and FDA approve this treatment for this child since he can die either way from the cancer and or from the treatment. At least let the poor child get some help even if it is in their eyes experimental in nature.
I bet POTUS would be singing a different song if Malia or Sascha needed the treatment.
So Obama is saying that he doesn’t care if the kid drops dead today. He won’t lift his finger.
Who’s potus???
I think the heading should read “WHITE HOUSE DOES NOT RESPOND TO COHEN PETITION”
im not sure why we put so much effort into these petition as we always get the same response
the whole we the people petition is a scam as Obama is!!!!
Daas – potus is an abbreviation for president of the United States
If Potus calls the FDA and says, “hey, these people want to try this drug, let’s let them” it will be done.
To No. 5. If it is in the best interest of Barak Obama, the White House has no qualms about influencing FDA decisions. The Potus simply issues an 3executive order, as he believes it is in his power to rule by fiat.
Insofar as to what kind of petition would be viewed with favor by the White House and might even be executed, consider asking the President to declare Michelle Obama’s birthday a national holiday.
Now that’s a petition that Obama would like.
The claim that the whitehouse does not influemce amy independent agencies is completely false. The heads of these agencies were appointed by the president and report ti him.
In the past the administration has given directives to the EPA, customs and immigration, homeland security, the state department etc. About which laws to enforce and how to enforce them. Do you actually think Obama will have no say in whether the Keystone XL Pipeline is approved, even though technicaly it falls under the State Departments purview.
The favt is if this was the presidents child or a Senator or congressperson’s child they would get the approval.
The answer that was received is a very well formulated way of saying “The president does not hold power in this arena, nor do you want him to start controlling the FDA. Refael Elisha’s best hope is to have the 100,000+ people that signed this petition email [email protected] a message stating that they should find the hour it takes the FDA to sign an exception for Refael Elisha.”
We are not on the level of Yosef Hatzadik, we need to do hishtadlus but do not put all your trust in “man”. Daven to Hashem, for only he can decide what is best in the end.