Life Science Compliance Update

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17 posts from July 2008

July 29, 2008

Grassley and Dingell: Wanted a New Sherriff for the FDA

We need a new Sherriff is the call of several key members of congress including (Senator Grassley, Republican from Iowa and Congressman John Dingell, Democrat from Michigan).

Between the Tomatoes or Jalapeño’s you make the call and the Chinese Heparin crisis,  plus a myriad of problems with post launch pharmaceuticals and devices.  These members of congress are calling for the FDA to change the way they fundamentally do business.

In a Wall Street Journal Article titled: Grassley, Dingell Lead Calls
For Overhauling FDA

According to the report:

The lawmakers say an FDA restructuring should build a much taller wall between the agency and the industry it regulates. The FDA would gain authority to recall drugs, which it can't do today, and to impose significant fines on drug companies for safety violations. The lawmakers also want the FDA to inspect generic-drug makers before approving a new product. Perhaps most importantly, they want the next president to appoint a tough FDA commissioner completely independent from the industry.

FDA officials "are too cozy with the companies they regulate," Mr. Grassley said, adding that new leadership must "fix the culture."

Billy Tauzin, president PhRMA, said he has warned members about what may lie ahead. "It's an accumulation of things some companies did over the years. Now it's death by a thousand cuts," he said in an interview. "We gotta stop the bleeding."

To lay the groundwork for their FDA overhaul, Messrs. Dingell and Grassley and their allies have ordered about 20 investigations of drugs and issues involving the FDA. Agency officials have spent hundreds of hours testifying before Congress.

In January 2009, one thing we can count on is a new administration and a new FDA Commissioner who will more than likely have no ties whatsoever to industry, so to all those academic physicians who are doing double duty as advisors to the presidential campaigns in the hope of landing the top FDA Job, if you have done research or spoken on behalf of industry there will be no need to apply for the commissioner’s job.

Wall Street Journal: Grassley, Dingell Lead Calls For Overhauling FDA

Drug Development – The need for a little serendipity

Why does drug development require so much serendipity?  Why do drugs take so long to develop?  Why is there are there so many troubles with the development pipelines of so many companies.  To help answer some of these questions David Shaywitz, MD and Nassim Nicholas Taleb wrote in an editorial in the Financial Times that Drug research needs serendipity.

Drug development takes a lot of hard work (“Science is hard spreadsheets are easy”) along with a certain amount of serendipity.

Serendipity is the effect by which one accidentally discovers something fortunate, especially while looking for something else entirely.

.The writers rightly focus that too much reliance on spreadsheets vs. better understanding of the mechanism of disease, has lead to many potential compounds being shelved.

Pharmaceutical companies are also waking up to the fact that perhaps they shouldn’t be doing everything and focus on their core competencies which may lay in sales, marketing, re-imbursement and regulatory compliance.

“If pharma companies want to stay in the game, their leaders will need to resist the false comfort of revenue predictions and valuation spreadsheets, and instead resolve to look uncertainty in the face, acknowledge its presence and embrace the opportunity it represents.

As policy makers consider new laws to restrict marketing of branded pharmaceuticals there needs to be some consideration of the complexity of the market place, and the complexity and art of developing new compounds.

I think we would all agree that this industry could use a little serendipity.

Drug research needs serendipity

July 27, 2008

Grassley: GAO Looks at Off Label Marketing

This weekend the Associated Press (AP) wrote a story FDA Faulted over unapproved uses of medications  about a draft of  a yet to be released report from the Government Accounting Offices (this is the investigation watchdog group for congress) on the FDA oversight of off label advertising.  The draft report is not complementary of the FDA citing that it takes an average of seven months for a company get cited for off label promotion and another four months for the companies to fix the problem and come in to compliance with the FDA.

So what is the extent of the “problem” From 2003-2007, the FDA issued 42 notices of possible violations, (this amounts to little over 8 violations per year) given the thousands of drugs and possible scenarios, this is a very small number.  When they are cited this usually prompted the drug maker to drop its promotional claims.

Senator Grassley is quoted in the article:

The situation has raised concerns for Sen. Charles Grassley of Iowa, who fears that federal programs such as Medicare and Medicaid are paying billions for medications used for questionable purposes while bulking up the bottom line for pharmaceutical companies. Indeed, a 2006 study suggested that more than 20 percent of prescriptions written in the United States are for off-label use. 

Un cited sources “2006 study” are not the same as real research, many of the off label uses of medications are following peer reviewed studies that show patients benefit from their use.  I would not want to tell the patient dying of cancer that “because the FDA has not approved this medication that would save your life, we can’t give it to you.”  We need to take a hard look at which is more important “saving lives and better quality of life for our patients or saving taxpayers dollars, and those are not necessarily the same goal.

The cases included a drug approved for breast cancer and rectal cancer that also was being promoted for treatment of gastric, cervical, uterine, ovarian, renal, bladder, thyroid and liver cancers.  Cancer is one of those questionable area’s for off label promotion, in that most agents work on multiple tumor types and if data is available that shows that lives can be saved by a new treatment it can take years for the FDA to give approval and in the mean time precious lives can be lost.

An additional 11 cases involving off-label promotions wound up in the hands of the Justice Department during the same period. Last year, for example, Bristol-Myers Squibb Co. agreed to pay the government more than $500 million to settle claims involving a series of alleged infractions, including promoting the drug Abilify — approved to treat schizophrenia and bipolar disorder — for treatment of dementia-related psychosis and for use in treating children.

This shows that the system may be working better than the reports stated; companies who pay $500 million dollar settlements spend a lot of resources to make sure they don’t make the same mistakes twice.  In addition other companies take notice and change their practices to avoid fines as well.

As is often the case in an election year, the GAO is more than happy to write reports that shed a unfavorable light on the administration especially if the president is from a different party than the party that controls congress.

It wouldn’t hurt the FDA to increase the size of DDMAC, the office at the FDA that reviews advertising but with more and more drugs going off patent that may not be a long term necessity. 

Senator Grassley’s chief concern is that Government takes too long to issue citations on off label promotion.    These are not traffic tickets, many of the citations can fall into “grey areas”, because of the complexity of labeling, and the fact that false claims equal huge fines, the FDA is entitled to taking their time to ensure they have all the facts correct, prior to moving towards citation (I admit seven months is too long, but perhaps three months is reasonable, but as is much with these types of reports the real number is probably closer to three months than seven)

Until we have evidence that there is actual patient harm or that the activity is actually happening, a slow and steady process might not be such a bad thing.   

When the GAO does get around to finalizing their draft “report” we will make it available here.

AP Story: FDA Faulted over unapproved uses of medications

MSNBC Reprint: Little monitoring for 'off-label' drug marketing


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