Congress Gives FDA 2 Years to Issue Social Media Guidance. All Bark, No Bite.

Congress Gives FDA 2 Years to Issue Social Media Guidance. All Bark, No Bite.

A little-noticed "Miscellaneous Provision" of the "Food and Drug Administration Safety and Innovation Act" (aka PDUFA, pdf), which was signed into law by president Obama on July 10, 2012, simply states:

SEC. 1121. GUIDANCE DOCUMENT REGARDING PRODUCT PROMOTION USING THE INTERNET.

Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance that describes Food and Drug Administration policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by such Administration.

Does that mean the FDA will deliver? If not, it wouldn't be the first time that a government agency missed deadlines imposed by Congress.

Usually, Congress specifies that regulatory agencies must issue regulations that spell out how to comply with the laws it passes. Regulations, therefore carry the weight of law. FDA Guidance (guidelines), however, is just FDA's current thinking on a topic. "It does not create or confer any rights for or on any person and does not operate to bind FDA or the public."

So, if FDA misses the deadline set by PDUFA, what can Congress do? Write a letter? Not another letter from Charles Grassley! I'm sure FDA is shaking in its boots.

The only thing interesting about this provision of the PDUFA act is why it was included and who lobbied to have it included? It couldn't have been Pfizer (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media"), but it could have been PhRMA (see "PhRMA Statement on FDA Social Media Guidance Delay").

Device Makers, e.g. Johnson & Johnson, May Benefit Most from FDA User Fee Bill

Device Makers, e.g. Johnson & Johnson, May Benefit Most from FDA User Fee Bill

"Put simply," says AdvaMed, the trade association of the medical device industry, "the [user fee agreement recently reached between FDA and the medical technology industry] is good for FDA; it is good for industry; and most of all, it is good for American patients."

The House version of the FDA user fee bill, which is currently being marked up, is "widely expected to contain more industry-friendly provisions, especially for medical device makers," according to Politico (here).

"One in particular is the HELP bill’s efforts to streamline the FDA’s ability to reclassify the risk level of devices. Whether a device is deemed more, or less, risky can dramatically change the amount of clinical data and other studies required for approval.

"Currently, such reclassification is a long-term rulemaking process that must be cleared by Health and Human Services and the Office of Management and Budget along with the full complement of public hearings and comment periods. The HELP bill would turn that into a faster administrative process without the extra layers of oversight."

According to Politico, AdvaMed is still pushing something in between "to preserve some of our due process rights,” AdvaMed's head of government relations (ie, chief lobbyist).

Details of "FDA’s ability to reclassify the risk level of devices" may be hidden in the bills. One of these details may concern "a loophole in the law that allows [medical device manufacturers] to submit new products to the FDA for instant review as long as they classify them as an upgrade even if the product has changes that could affect safety," says Consumer Reports. "Companies now use the process 90 percent of the time, according to a report published by Rep. Ed Markey, D-Mass., who is an advocate for industry reform."

Meanwhile, the FDA wants to assign a new bar-code-like identification number to medical devices to help it detect malfunctions in devices AFTER they have been approved. By tapping into medical and billing records from hospitals and insurance companies, FDA hopes to identify faulty devices before they cause deaths, such as the 686 deaths from 2009 to last year connected to automated external defibrillators and at least 20 deaths recently linked to surgically-implanted heart defibrillator wires.

One of the leading manufacturers of heart defibrillation devices is Guidant. A few years ago, it had to recall one of its devices that was linked to several deaths (see NYT article). That derailed a takeover bid by Johnson and Johnson (JNJ). Meanwhile, JNJ is actively growing its medical device business and will soon acquire Synthes -- a Swiss manufacturer of orthopaedic devices -- for $21.3 billion. Devices now account for 40% of JNJ's worldwide sales (see chart below; source of data: CNNMoney.com and Q1 2012 financial statement).

JNJ may position itself as a "consumer" products company, but its  main business is pharmaceutical drugs and medical devices. With the acquisition of Synthes, which had sales of nearly $4 billion last year, JNJ's device business will be an even bigger slice of its global sales pie (maybe 43%).

FDA Moves the Cheese on Drug Approval Numbers

FDA Moves the Cheese on Drug Approval Numbers

The FDA and the pharmaceutical industry are bragging about the number of "new" drugs approved in "fiscal year" 2011 (October 1, 2010 through September 30, 2011). In a report (find it on the FDA site here), FDA said it approved 35 "innovative drugs" during that period. PhRMA -- the drug industry's trade association -- said that 35 "new molecular entities" received FDA approval in fiscal year 2011.

One has to be careful about how you define a "new" drug in order to compare one year's performance to another. Also, there's the fiscal year numbers vs. the calendar year numbers.

For example, "new molecular entity" is a well-defined FDA term that even has an acronym: NME. FDA defines a New Molecular Entity as "an active ingredient that has never before been marketed in the United States in any form." NMEs go through a New Drug Approval (NDA) process.

In its report, FDA does NOT say there were 35 NDAs approved in FY 2011 as would be inferred from PhRMA's statement. Instead, FDA uses the term "innovative drug," which it does NOT define. It does, however, also refer to 35 "new drugs." Typically, FDA would use these terms to mean NMEs.

It's all a bit confusing to us mice trying to find the "cheese."

Let's look at the data on a calendar year basis.

FDA has new drug approval data available on its web site here. These data -- reported on a calendar year basis -- include NMEs (usually small, non-biological molecules) and BLAs (biologics license applications). The latest available data covers calendar year 2010 during which FDA approved 15 NMEs and 6 BLAs for a total of 21 total "new drugs."

Unfortunately, we cannot compare the number 35 for FY 2011 recently mentioned by FDA and PhRMA with the number 21 for calendar year 2010 to determine how much better the FDA/drug industry is doing. Obviously FDA wants to paint the rosiest of pictures in order to justify approval by Congress of new user fees being paid to the FDA by the drug industry to "expedite" the approval process.

So, how many NMEs and BLAs has the FDA approved so far this CALENDAR year? Well, on July 7, 2011, it was reported that FDA approved 20 "new drugs" as of that date, "just one short of the total for all of 2010, according to a top agency official" (see "2011 New Drug Approvals May Exceed 2010 Total, But...").

On FDA's Drugs@FDA, you can search for "Original New Drug Approvals (NDAs and BLAs) by Month," which includes all applications approved for the first time during the selected month including New Molecular Entities (NMEs) and new biologics (note: "Not all biologics are in Drugs@FDA"). Anyway, accessing these data, I come up with 23 "new drugs" (NMEs). Or maybe it's 25, which includes two "drugs already marketed, but without an approved NDA." In any case, calendar year 2011 is shaping up better than calendar year 2010.

FYI, I've plotted the yearly data from 1994 through 2010, which clearly distinguishes between NMEs and BLAs (see chart below).

Angry PhRMA, Level 1: PDUFA

Angry PhRMA, Level 1: PDUFA

Yesterday I suggested a real "kick-ass" pharma-related game would be ANGRY PHRMA (see "Pharma & Fun, Not Oxymoronic? Here Comes Gamification!"). Below is shown "Level 1: PDUFA," the goal of which is to "knock down" those Senators trying to give FDA new regulatory powers as part of the bill -- or as PhRMA describes it, those "additional provisions that could create unintended burdens on the regulatory process" (see "PhRMA Statement Regarding Prescription Drug User Fee Act Reauthorization"). PhRMA specifically disagrees with REMS because it “has led to a breakdown in FDA’s review process and has eroded some of the positive progress derived from earlier PDUFA agreements" (see "PDUFA 2012 – Background From PhRMA’s Perspective").

OK, that's the boring, policy wonk explanation. Let's get down to  some serious Senatorial "butt whooping" fun!

EXTRA CREDIT: Name at least 2 Senators that PhRMA needs to work on.

I'll try and come up with more levels of play for my ANGRY PHARMA game, but I need your help. Suggest an issue that PhRMA is or needs to be angry about and who the adversaries (little piggies) are. Also, describe the pigs' fortress that the Angry PhRMA Birds must knock down.

Pharma Walks, Devices Balk When It Comes to FDA User Fees

Pharma Walks, Devices Balk When It Comes to FDA User Fees

While brand name drug manufacturers pay about 62% of FDA's $930 million drug review budget, medical device companies only pay about 20% of FDA's $292 million budget allocated to reviewing devices (see "Pharma Pays 62% of FDA's Drug Review Budget").

Are device manufacturers cheap skates?

I don't think so. My guess is that they don't have as many sympathetic people inside FDA as does Big Pharma. Why else would the device industry and its allies have been "especially vocal this year in denouncing what they perceive as the relative length and unpredictability of the FDA's device-approval process"?

Big Pharma on the other hand is suspected to have close ties to DDMAC. Of course, it cannot be proved that FDA plays favorites depending on how much of the bill is paid by the companies it regulates. However, I am keeping tract of two trends:

1. the rise in PDUFA (the 1992 Prescription Drug User Fee Act) fees (ie, user fees) and 
2. the number of warning letters FDA sends each year to pharma companies. 

I get the former data straight from the FDA (here) and the latter from EyeOnFDA blog, which monitors warning letters (here, for example). The following chart shows the trends:

It appears that 2010 saw a slight decrease in user fees received by FDA, but this is an early estimate that is sure to be higher in the next report. In fact, the WSJ article cited above indicates that "the Food and Drug Administration has reached an agreement with the brand-name drug industry on a five-year plan that will increase industry fees paid to the agency by about 6%." I'm pretty sure they are talking about a 6% increase EVERY year for the next 5 years. The average yearly increase over the past 12 years has been 16.7%. Hmmm... I guess the FDA expects to be reviewing fewer new drug applications in the coming years than in the past.

P.S. In 1997, only 36% of FDA's drug review budget was paid for by pharma user fees.