This is it!  Memorial Day weekend!  BBQs, straw hats, white pants, white bucks, seersucker suits and shorts, flip flops, the beach, clam bakes, trashy novels, front porch rockers, fresh baked fruit pies, beefsteak tomatoes, corn on the cob!  Ah summer!

In the meantime, as we slip into summer like a pleasant warm bath, here are a few things of interest from this week:

• PDUFA Legislation Clears the Senate – The Senate passed PDUFA legislation known as S. 3187 - the FDA Safety and Innovation Act – yesterday by a 96-1 vote and expanding user fees until 2017.  Who would have guessed?  Bloomberg reports that the House may be voting on the legislation by next week.  The FDA Law Blog has carried an outstanding overview of the amendments that passed along with the Senate legislation.
• Drugmaker Offers App as Drug Goes Generic – When a drug is going to face generic competition, it is important to consider ways for the brand name to offer a premium that comes with the brand in order to set it apart from the generic.  Years ago that might have taken the form of some kind of support tool offered through a web site.  That might be outmoded today when instead it might mean offering support for brand users through the use of an app.  This week Pfizer announced a partnership to provide an app to provide support for people on Lipitor.
• FDA Holding Public Meeting on International Food Safety – On June 19, from 9:00-5:00 FDA will be holding a public meeting entitled “International Capaicty Building with Respect to Food Safety” at the L’Enfant Plaza Hotel in Washington, D.C.  FDA states that the purpose of the meeting is to provide interested parties the opportunity to discuss the agency’s plan to expand the capacity of foreign governments that export food to the U.S.  The closing date for registration is June 11, 2012 and the closing date to submit either electronic or written comments is set for July 20, 2012.

That’s it for me this week.  As we begin the summer, let’s also remember and honor the valor of the fallen.  Have a good weekend everyone.

Photo credit:  Anne Hainsworth.

It goes without saying that as Twitter develops as a platform, the uses of it increasingly vary.  In fact, Twitter allows not only for a breadth of uses – from journalistic to scientific – but a depth as well (despite being only 140 characters) by allowing very specific audiences access to very targeted information.

A highly regulated industry like the medical products industry is often perceived as highly inhibited when it comes to social media. While it is true that such industries have to take care in their use of all communications in general, and social media in particular, there is nevertheless an increasing use of these platforms by the pharmaceutical, biotech and medical device sectors – collectively herein referred to as “pharma”.

Pharma has put Twitter to use on many fronts.  One is jobs and recruitment, both within the U.S. and outside of the U.S.  There are now at least 21 pharma-sponsored Twitter feeds set up, some with more activity than others.

The scale is impressive.  By my count, there have been nearly 27,000 tweets sent out by pharmas about available jobs.  Some companies, such as Roche, have tweeted a lot of jobs, while others are relatively quiet even though they come from big companies, indicating that they have not fully committed.  Still other companies have multiple feeds regarding jobs and some have feeds for U.S. specific jobs and some specific to other countries.

And there is interest in these feeds.  There are nearly 19,000 followers who are following those feeds – though of course that does not likely represent 19,000 different people.

After all, I follow them all.  In fact, as many are aware, on the Eye on FDA Twitter feed there is a list so that for those interested – you can subscribe to the list and see only pharma jobs being tweeted by all the pharmas, including one from NIH.

I kept thinking that this was going to be Memorial Day weekend and I was wrong each time, but it is Victoria Day weekend in Canada, so perhaps I was just channeling a 3-day weekend from my northern friends.  Happy Victoria Day Canada!

And as we approach our regular old weekend, here is a bit of what happened this week:

• FDA AdComm Gives Thumbs Up for First Home HIV Test – This was of particular interest to me after my many years of working on HIV testing and policy issues when working for HIV advocacy organizations in the 1980s and 1990s.  Back then there were a lot of concerns about how a self-administered HIV test might be utilized.  This week, OraSure saw a unanimous vote from an advisory committee meeting to consider the company’s at home HIV test called OraQuick.  This is certainly a development to watch.
• First Stem Cell Drug Approved – And speaking of Canada and speaking of firsts, this week Health Canada approved the world’s first drug derived from stem cells for the treatment of graft-vs-host disease (GvHD) in children.  The drug, Prochymal (remestemicel-L) is made by Osiris Therapeutics will be administered to children with the condition who fail to respond to steroids.  The drug is manufactured from mesenchymal stem cells (MSCs) which are derived from the bone marrow of health adult donors between 18 and 30 years of age.
• First Approval of Generic Plavix! Ok, speaking of firsts, and speaking of approvals, FDA announced this week that the agency was approving the first generic versions of blood thinning Plavix (clopidogrel bisulfate) which is used to treat patients who have had a recent heart attack or stroke and have arterial blockage.  Several companies received approval for varied doses.

I’m out of firsts, Canada connections and approvals for now.  If you are in Canada, have a wonderful holiday weekend!  If you are not, have a wonderful regular old weekend.

Note:  After initial publication, this post was modified to include the name of the at-home HIV test kit reported in the second item.

Another quarter has zoomed by.  And with it, FDA’s Office of Prescription Drug Promotion (OPDP), formerly known as the Division of Drug Marketing, Advertising and Communications (DDMAC), has issued a stream of regulatory action letters known as Notice of Violation (NOV) letters or Warning Letters (WL).  And on a quarterly basis, we take a look to see what regulatory wires were tripped.

In the last quarter of 2011, the pace at OPDM had picked up a bit having issued 9 letters. However, over time, the pace seems to have slowed a bit from year to year.  And during the first quarter of 2012 there were a total of 6 letters issued, 1 WL and 5 NOV letters.

The 6 letters contained 18 violations by my count.  One of the most notable things from this quarter however was in the frequency of some violations and lack of others.  The minimization or omission of risk information has almost invariably been by far the most frequent violation cited in regulatory action letters.  One of the less common violations is the promotion of an unapproved use.

However, this quarter there were only two Minimization or Omission of Risk violations noted, but there were two also for unapproved use promotion.  Here is the complete breakdown:

• Overstatement of Efficacy – 6
• Unsubstantiated Claims – 5
• Promotion of Unapproved Use – 2
• Omission or Risk Minimization – 2
• Omission of Material Facts – 2
• Broadening of Indication – 1

The vehicles that carried the communications involved 3 traditional print items, 2 digital (Websites) and 1 oral statement made by a presenter.

With the frequency of violations this quarter in overstatement of efficacy and unsubstantiated claims, it appeared that a common pitfall was the description of patient experiences that, while they may have been accurate, went beyond what the typical patient experience might be or went beyond what was reflected in the label.

Wondering by the end of the day how many people will post “May the 4th be with you” on Facebook.  So far I am in double digits….

We are in May.  Hard to believe.  I am thinking that there are many signs of a long, hot summer.  Just what we need in an election year.

In the meantime, here are a few things that happened this week:

• CMS Announces Delay in Sunshine Act Reporting – You may remember that CMS already missed one important deadline for implementing the provisions of the Sunshine Act in October 2011 for publishing a proposed rule which CMS eventually did do in December.  Recall also that recently Senators Charles Grassley and Herbert Kohl sent a letter to CMS expressing their desire that the agency issue a final rule no later than June 2012 on the collection of data, but that is not happening.  In a blog post on May 3, CMS let it be known that they received over 300 comments on the proposed rule during the comment period.  Saying they would issue a final rule “later this year” CMS also stated that data collection would not begin before January 2013.
• FDA Approves Gaucher Disease Drug – The agency announced this week that it was approving a new orphan drug Elelyso (taliglucerase alfa) – a long-term enzyme replacement therapy for treatment of Gaucher disease. Gaucher disease affects about 6000 people in the U.S. and causes a build up of fatty materials in various organs.  The drug is manufactured by Pfizer.
• Facebook Pushes Organ Donation – Apparently there is  ”Like” button for almost everything – after an initiative that allows folks on Facebook to opt into organ donations, several states saw a spike in willing donors.  When you think about it, Facebook does have lots more people in their ranks than the Department of Motor Vehicles.
• The i’s Have It – i-Phone App Approved for Blood Glucose Monitoring – As many regular readers may know, I have a device that hooks up to my i-Pad to take my blood pressure.  Well now diabetics have i-support as well with the approval of the new Sanofi US blood glucose monitoring system.  It is the first FDA cleared blood glucose meter to directly connect with an iPhone or iPod touch.  Check out the multi-media news release for photos, video and more.

That’s it for me this week.  Have a good one everybody.

On April 30, 2012 the GAO released a report entitled “FDA Has Met Most Performance Goals for Reviewing Applications” where the title pretty much sums it up.  FDA has been doing well in terms of meeting goals related to the approval of new prescription drugs.  Ed Silverman at Pharmalot supplied a very nice overview of the findings and I leave it to his more capable hands on reporting both the report and some of the circumstances surrounding it.

However, one of the collateral benefits of such a report is that in reading it, one gets a good deal of context for understanding how things work.  FDA is a huge agency and there is a tremendous amount of nuance to the various parts of its operations.  There are many printed materials scattered throughout the Web site that often explain policies and procedures, and there are helpful statistics, but they are not often found in one spot.  By reading this report, one gets some insights without having to perform the search  - a true treasure trove of information.

For example:

• User fees have become a larger part of FDA’s funding for drugs – rising from 26.1 percent of costs in FY 1993 to 61.5 percent in FY 2010;
• The fee for the review of an application (NDA or BLA) that requires clinical data is $1,841,500 and half that if it does not require clinical data in FY 2012;
• A sponsor does not need to request priority review, FDA assesses all applications for priority review eligibility and if it is granted, the sponsor is notified within 60 days of the start of the review period;
• FDA convenes an advisory committee meeting for all applications for NMEs and original BLAs unless an adequate justification is documented explaining the decision not to hold a meeting (though the details of where one finds this were not included…);
• If a sponsor gets a Complete Response Letter (CRL) and resubmits, the review of the resubmission is covered under the user fee paid with the original submission and is either a Class 1 or Class 2 resubmission;
• A Class 1 resubmission contain only certain information such as draft or final printed labeling, safety or stability updates, or other minor clarifying information;
• FDA may consider a sponsor’s failure to take action within a year after the issuance of a CRL to be a request to withdraw unless an extension has been requested in writing.

Those are a few of the interesting factoids picked up by reading the report.  Of course, if you read the report, you also get the download of the main subject matter – how well FDA is doing on approval times – which is “pretty good.”

The issue of drug shortages has surfaced periodically in the news and in policy circles for months, prompting both FDA and the Administration to various actions.

For some, it may be an abstract notion – the idea that some drugs may be in short supply.  For patients, however, who may face the hard reality of those shortages and for the physicians who treat them, it is far from abstract.

Late in 2011, the IMS Institute for Health Informatics decided to take a look at the issue through a lens of their own making to see if the problem could be better defined.  Through its extensive collection of prescription data, IMS can analyze a wealth of information to provide important insights into our consumption and use of medications in the U.S., and compiling it into a report.

The resulting report was entitled “Drug Shortages:  A Closer Look at Products, Suppliers and Volume Volatility” and what it found was that the drug shortage problem is very concentrated among certain types of drugs – generics and injectables.  Late last week, I had the opportunity to ask Murray Aitken, Executive Director of the IMS Institute for Healthcare Informatics, what made the IMS outlook unique, about the key findings, and what could help not only in the early detection of drug shortages, but in their prevention in the first place.

Here is the podcast of our discussion where I asked what unique ability IMS brought to the table in assessing the situation and what insights resulted.

See also FDA’s Web page on Drug Shortages

10 Count ‘em 10.

That is how many Warning Letters the agency sent out last Friday to manufacturers and distributors of dietary supplements.  The specific focus of the letters was products that were being marketed containing dimethylamylamine, also known as DMAA, sold as a “natural stimulant”.

The list contains 10 different manufacturers covering 15 separate products.

The specific violation cited in the letters was that current law states that when supplements contain dietary ingredients not marketed before October 15, 1994, manufacturers must submit the new ingredient for use as a New Dietary Ingredient, notifying FDA of evidence that supports a conclusion that use is safe.  The agency said in the letters that this requirement had not been met.

Further the agency stated that the synthetic DMAA could not be a “dietary ingredient” under Dietary Supplement Health and Education Act of 1994 (DSHEA) which defines a dietary ingredient as a “vitamin, mineral, amino acid, herb or other botanical, a dietary substance for use by man to supplement the diet, or a concentrate, a metabolite, constituent, extract or combination of these substances.”

FDA has been known in the past to send out a flock of letters at once to stake out a policy decision.

The action appears some time in coming.  DMAA has been marketed as a supplement appealing to fitness buffs seeking extra energy. The Army Times reported in December 2011 that the Department of Defense was pulling DMAA containing products from on-base sales pending a review of side effects after some the experiences of some soldiers.

More information on how the agency regulates dietary supplement is contained on an overview page at the FDA site.

Lately I have been on hiatus.  It was not a planned one, but brought on by a convergence of circumstances that I’m happy to say includes being extremely busy.  That said, I have missed writing my postings and have stored up a lot to talk about – so fair notice here – I am back in the saddle.  I’ve been working on a number of things including a White Paper that I will publish here in the coming weeks that I think folks will find insightful.  Stay tuned.

In the meantime, here is a bit of what happened this week (I’ve still been keeping track):

• Doctors and Social Media in the UK – According to an editorial in The Lancet this week, the General Medical Council which oversees the practice of medicine in the U.K. issued a draft guidance for comment on the use of social media by physicians for consultation.  The draft covers a number of issues related to patient confidentiality, appropriate conduct, and the like.  An editorial in The Lancet notes that accepting patients as friends on Facebook is particularly discouraged, though notes that it is important that physicians look for ways to seize the opportunities offered by social media to help steer patients who have gravitated there for information and not to solely focus on the risks.
• Bayer Gets Pintresting - And speaking of social media, this is a story that ran earlier this month but too interesting not to mention.  Here at Eye on FDA for some time, I have been tracking the involvement of pharma companies in blogging, Facebook, YouTube and of course, Twitter.  With the emergence of Pintrest, many have wondered if there is utilization there for pharma.  According to an article in MedCity News, Bayer is pioneering an effort in the new platform. According to the article, the company has established three bulletin boards – one on sustainability, one on innovation and one on the breadth of the corporation.  It will be interesting to see whether others follow and how they will utilize it to engage stakeholders.
• FDA Approves New Orphan Drugs – Two drugs were approved by the agency this week of note, both on the 26th.  The first was GSK’s Votrient, already approved for advanced kidney cancer,  for use in treatment of advanced soft tissue sarcoma, an orphan disease with about 10,000 cases in the U.S. annually.  In addition, this week FDA approved Novartis’ Afinitor for the treatment of non-cancerous kidney tumors – also an orphan disease. Afinitor was also previously approved to treat advanced renal cell carcinoma.

That’s it for me this week.  Have a good weekend everyone.  Good to be back!

Yesterday Senators Kohl and Grassley submitted a letter to CMS seeking information on the implementation of the Sunshine Act – the legislation passed and signed into law that would put into place a system for public reporting of the financial transactions between medical product manufacturers and medical providers.  Many will recall that last fall, CMS missed the deadline for outlining its plans for how it would collect and report on financial transaction data.  At the time that prompted a letter from Senator Grassley inquiring when the agency would get around to doing so.  Yesterday, another letter went out.

“We are disappointed that regulations implementing the Sunshine Act were not complete by the statutory deadline of October 1, 2011.  We request that the final rule on implementation be released no later than June of this year so that partial data collection for 2012 can commence.”

In addition, there was some specific direction.  In the letter they urge that CMS define very specific categories for payments and urged a removal of a catchall “other” category that could serve to obscure the nature of some transactions.  In addition, the Senators took issue with the proposed yearly schedule for correcting mis-reporting to the public site stating rather that errors should be corrected as the error becomes known.

Additionally the letter expressed concern regarding the design of the Web site that will serve as the vehicle for reporting the information to the public.  Given the potential for public attention to the information – and the many ways that information can be interpreted – the Web site clearly takes on as important a role as the very type of data that is collected.  Therefore, the letter urged that the site be thorough and user-friendly complete with definitions to understanding the nature of the transactions and all of the entities involved.

The letter closes by posing a set of particular questions:

1. Can CMS commit to completing a final rule by this summer so that data collection can begin in 2012?
2. Since CMS missed the initial required Congressional deadline, has CMS increased the resources or personnel assigned to the implementation of the Sunshine Act, including a dedicated information technology lead?
3. Will CMS commit to issuing an RFP to begin designing the website?
4. Does CMS have a dedicated working group assigned to the implementation of the Sunshine Act, and what technical expertise and program areas are represented?
5. Does CMS have a public education and outreach plan to raise awareness of the new law with the provider community and with health care consumers?
6. Has CMS allocated dedicated implementation funds for the Physician Payment Sunshine Act?

While these are questions posed by the Senators to CMS, medical product manufacturers may do well to ask themselves variations along these lines.  Many have voluntarily begun to report data on their Web sites, but that may have to be changed to more accurately reflect the categories and prominence of the CMS undertaking.  How will mistakes in reporting be dealt with?  How will patients and providers be educated?  Even as CMS ponders its response to these inquiries, it is a good time for all to consider what form individual company responses will take.