Pharmaspective

Maryland Device Manufacturer Licensing – Form Over Substance

“The way to get started is to quit talking and begin doing.” - Walt Disney

 There are certain fundamental truths within state regulatory frameworks.  One such truth is that some statutes or regulatory requirements are inexplicable.  These requirements leave you scratching your head muttering to yourself “what were they thinking?”  The answer to that rhetorical question is that sometimes they weren’t thinking.  State legislative bodies make mistakes.  A statute or regulation generally makes sense to those who sponsor and support it.  It often isn’t until companies attempt to comply that the error or omission comes to light.

 It is my humble opinion that the Maryland legislature has made an honest error that will have a profound impact on the device industry.  Maryland has two different applications for distribution licenses.  As authorized by state law, FDA licensed manufacturers can use the abbreviated form.  Wholesalers, on the other hand, are required to use the long form which adds the extra requirements of fingerprinting, the posting of a surety bond or other form of security, and depending on the state of residence, obtaining certification from the National Association of Boards of Pharmacy ("NABP") as a Verified Accredited Wholesale Distributor (“VAWD”), a lengthy and costly process.

 So where is the error you ask?  A device manufacturer, unlike a drug manufacturer,  must file the long form application, post surety and may be required to obtain VAWD certification before they can be properly licensed to distribute prescription medical devices into the State of Maryland.  How can this be?  I believe that it is merely an oversight by the drafters of the Maryland statute.  The Maryland Statute provides that “the information and qualification requirements for obtaining a permit under this subtitle, beyond that required by federal law, do not apply to a manufacturer who distributes its own prescription drugs.”  Md. Code Ann., tit. 10, subtit. 34, 22 § 12-6c-03.   As prescription devices are a separately defined term, the State Board of Pharmacy has determined that it can apply the relaxed requirements only to prescription drug manufacturers and not to prescription device manufacturers.

 There is no legitimate legislative or public policy purpose in holding an FDA registered device manufacturer to a higher standard than the manufacturer of prescription drugs.  As the state licensing laws are in place to ensure the integrity of the drug supply and prevent diversion and abuse, less stringent requirements are often imposed on device manufacturers.

 When confronted with such an apparent injustice there are two paths you can follow.  The first is to begrudgingly comply and lament the injustice that has befallen you.  The second is to try to right the wrong.  If you have a governmental affairs department, call them.  If you are a member of AdvaMed, call them.  If you work with outside lobbyists, call them.  If you have access to none of those resources, then call the Maryland Governor’s office.  The fix is simple.  The addition of three simple words “or prescription devices” will bring the statute in line with its obvious intent.  Take action.

Frank Fazio

Democrats Set Sights on Medical Device Safety Regulation

“Forewarned, forearmed; to be prepared is half the victory.” - Miguel de Cervantes

Ink-like clouds suffused over our nation’s capitol as a murder of crows converges upon fresh carrion. As the atramentous nebulae congealed over the Hill, the icy, soul-sucking breath of regulators chilled the device industry like Harry Potter’s tormenting dementors. Yes, my friends, Congress is coming and it has medical devices locked in the cross-hairs.

There is no subtlety as the portents blaze like neon along a moonless desert highway. In 2011 there were four congressional subcommittee hearings on the FDA’s regulation of medical devices. Unsatisfied with their colleagues on the other side of the aisle, Democrats, led by Henry Waxman (D-CA) as ranking member of the Committee on Energy and Commerce (“ the Committee”), have been advocating increased regulation of medical devices. In an October 12, 2011 letter to Fred Upton (R-MI), Chairman of the Committee, Joseph Pitts (R-PA), Chairman of the Subcommittee on Health, and Cliff Stearns (R-FL), Chairman of the Subcommittee on Oversight and Investigation, Waxman and colleagues Frank Pallone (D-NJ), Diana DeGette (D-CO) and John Dingell (D-MI) urged the Committee to hold hearings on device safety in conjunction with the impending reauthorization of the medical device user fee program. The letter detailed safety concerns with brain stents and metal-on-metal hip implants. Waxman et al. contended that the hearings held in 2011 focused on delays in approval and overregulation while ignoring serious health concerns. You can read the full text at http://democrats.energycommerce.house.gov/index.php?q=news/energy-and-commerce-democratic-leadership-calls-for-further-examination-of-fda-medical-device-r

A second letter was sent on January 20, 2012 by Waxman, DeGette, and Dingell renewing their prior request for hearings. This communication detailed concerns over the “Lap Band” gastric band and urogynecologic surgical mesh. The authors concluded by requesting the Committee hold hearings to determine “whether FDA device regulation has been ineffective in protecting the public from dangerous medical devices” and urging the Committee to obtain documents in regard to the Lap Band and surgical mesh. Waxman again tied this review into the reauthorization of the Medical Device User Fee Act noting that “we [Congress] need to understand the safety of devices on the market, the tactics device manufacturers and others use to market these devices, and the extent to which these tactics may increase risks.” Full text of letter at http://democrats.energycommerce.house.gov/index.php?q=news/democratic-committee-leaders-call-on-committee-republicans-to-hold-hearings-on-dangerous-medica

If you remain doubtful that Democrats are setting up device safety as an election year issue, then you likely missed President Obama’s State of the Union Address. Buried deep in the President’s remarks, it inconspicuously passed in a heartbeat. But it was there and worthy of repeating:

“We’ve all paid the price for lenders who sold mortgages to people who couldn’t afford them, and buyers who knew they couldn’t afford them. That’s why we need smart regulations to prevent irresponsible behavior. Rules to prevent financial fraud, or toxic dumping, or faulty medical devices, don’t destroy the free market. They make the free market work better.” President Barack Obama’s third state of the union address to Congress, January 24, 2012.

It was there. Just four days after Representative Waxman’s second letter to the Committee, the President slipped device safety regulation into the State of the Union. There can be no doubt that democrats are setting this up for an election year showdown. Although the President’s remarks are couched in terms of safety, Waxman specifically tied safety into marketing tactics. There is certainly evidence that impending regulation will not simply address safety in the approval process but will further impose stricter regulatory oversight of device marketing.

You have been forewarned. In the immortal words of Rubeus Hagrid, “It's changing out there. ... There's a storm coming, Harry. And we all best be ready when she does.”

Happy New Year! The FDA provides guidance on responding to “public” unsolicited requests for off-label information.

By: Frank Fazio

While the pharmaceutical and device industries are enjoying the Holiday break, the Food and Drug Administration (“FDA”) released a draft guidance for comment that will soon be published in the Federal Register.  The document, entitled “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” (“Guidance”) provides much needed insight into FDA’s current thinking about those pesky “public” requests posted on web sites or in social media.

 The Guidance applies to unsolicited requests for information about unapproved uses of prescription drugs and biological products.  It also applies to medical devices marketed for a specific use without  product approval or clearance.  In regard to such devices, the FDA notes that a request for off-label information would include any use for which approval or clearance would be required.

 Through the use of various examples, the Guidance attempts to establish the boundary between solicited and unsolicited requests for off-label information.   Making that determination has always been the first step in deciding whether a response is appropriate.  The FDA concedes that internet and social media have provided new outlets whereby companies might be confronted with an unsolicited request for off-label information.  The Guidance classifies such requests as either non-public or public.  Non-public requests are those that are privately directed to the firm and are not visible to the public at large.  We all know what to do with those requests, although the Guidance reiterates and reaffirms the standard principles.  More interesting are the public requests.  The FDA defines these as “an unsolicited request in a public forum, whether directed to a firm specifically, or to a forum at large.”  The FDA notes that such requests can occur on company sponsored sites as well as on sites run by third-parties.  The FDA recognizes that it is in the interest of the public to permit the company to respond to such requests rather than relying on speculation and the misinformation that might be provided by other lay people on a thread.

 So how can the company respond in a compliant manner?  The FDA has determined that a response to a public request, whether on a company or third-party site, should be answered in a private manner.  The FDA cited concerns about the dissemination  of information to other individuals who did not make the unsolicited request as well as the enduring nature of a posted response.  The Guidance notes that a firm’s public response to a public request should clearly convey that the question pertains to an off-label use along with specific contact information for the medical or scientific personnel (e-mail, phone, etc.), so that the individual can follow up for additional information.  The individual providing such information must clearly disclose their involvement with the firm, and the response may not be promotional in any regard.  The public response should also include a direct link to the FDA approved labeling, but may not include links to any other information (e.g. firm or product websites, third-party websites, or other promotional materials).  Likewise, the URL for the labeling should not itself be promotional in any way.  By way of example, the Guidance notes that www.bestcancercure.com would not be an appropriate URL for the product label.  If the individual that made the public request then contacts the medical or scientific personnel, the request is then treated as any other non-public request.    

 The Guidance is well thought out and makes sense.  It permits firms to provide appropriate information in response to public requests without fear that such responses will lead to claims of off-label promotion.  The full text can be found at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM285145

Happy New Year!

Google+ Pages: Should the Life Sciences Industry be Concerned?

Facebook, MySpace, Twitter, YouTube . . . the list of social networking platforms continues to grow and now Google has its own.  In an effort to take “[a] leap forward in building relationships between businesses and people[,]” Google recently launched Google+ Pages (“Google+”).  So, what does Google+ mean for the life science industry?  To date, forty million users, including a number of life sciences companies, have signed up and created pages for themselves and/or their businesses.  Will Google+ be a new source of liability or a great new way to interact with industry members and consumers?  The answer is both. 

Google+ is a social networking hub that allows users to connect through three key features, some of which are similar to those in Facebook.  First, Google+ is centered around “circles,” which are similar to Facebook’s “friends” feature.  The circles provide the basis for Google+ interactions and they are created and maintained by each user.  For example, a Google+ user (“user”) that is a member of the life sciences industry could create the following circles:  employees, consumers, healthcare professionals, investors, and industry members.  The user places each member it connects with in one or all of these circles and this placement determines the information that the member can see.  Second, posts and comments are placed in each circle’s “stream,” which is similar to Facebook’s “wall.”  Streams are visible to all members of the circle.  For example, when a life sciences company places a post in its healthcare professional circle’s stream, it can only be viewed by healthcare professional circle members.  However, posts can be “reposted, ” or taken out of a circle and shared with other members, even without user’s permission.  Although reposts appear to be problematic for life sciences companies, Google+ recently announced that it is rolling out a feature that allows you to “lock” your post before sharing it, therefore, eliminating the risk of unauthorized reposts.  Third, Google+ has a “hangout” feature that allows for group video chats.  Hangouts are initiated by a Google+ user who then invites members of its circle to attend.  However, once the invitation is sent, those invited could forward the invitation to anyone.  Although Google+ allows users to block specific members from the hangout, it does not allow users to disable invite forwards.    

The potential benefit of Google+ is obvious.  The life sciences industry can reach new and different audiences while applying specific rules for communications with each different audience.  For example, the company that creates circles for employees, consumers, healthcare professionals, investors, and industry members can apply specific controls to each and limit the information that is visible by the circle.  Furthermore, companies can take extra steps to lock posts and disable, or at least preview, comments before they are posted.  Thus, Google+ provides a great platform for companies to get information out to the public in a controlled manner without some of the known risks associated with Facebook, which generally no longer provides life sciences companies with the ability to disable comments.  However, companies should proceed with caution.  For instance, hangouts could still present some difficulties for life sciences companies because the user still cannot disable invite forwards.  In addition, the life sciences company must fully understand the nuances of Google+ in light of its business model before it can gauge the risk it will take.

A Holiday Present from CMS: Proposed Regulations Implementing Sunshine

More than 2 months after the October 1, 2011 deadline, the Centers for Medicare and Medicaid Services (CMS) has finally released the proposed rule that would implement the “Transparency Reports and Reporting of Physician Ownership or Investment Interests” section of the Patient Protection and Affordable Care Act (often referred to as the “Sunshine Act”).   The proposed rule would require manufacturers of drugs, devices, biologicals, and medical supplies covered by Medicare, Medicaid, or the Children’s Health Insurance Program to report  payments or other transfers of value made to physicians and teaching hospitals.  It would also require manufacturers and group purchasing organizations (GPOs) to disclose physician ownership or investment interests.  Although the proposed rule is not scheduled to be published in the Federal Register until Monday, CMS issued a notice of proposed rulemaking yesterday and actually made available the unpublished rule.

So, what are the implications on timing for data collection and reporting?  In a lengthy preamble accompanying the draft rule, CMS is proposing that manufacturers and GPOs would not be required  to begin collecting data for federal disclosure on January 1, 2012, but that they will be able to wait until the final regulations are issued sometime in 2012.  As a result, manufacturers and GPOs would submit a disclosure report for only part of 2012 on March 31, 2013.  CMS will then aggregate these submissions and provide physicians and teaching hospitals 45 days to review the information before it is made publicly available by September 30, 2013.  Applicable manufacturers and other interested parties will have until 5 pm Eastern Standard Time on February 17, 2012, to submit their comments on the proposed rule electronically; by regular, express or overnight mail; or by hand or courier. 

Many in industry have been working frantically to meet the January 1, 2012 deadline to begin data collection, and perhaps some companies will forge ahead as planned and begin collecting, and perhaps voluntarily reporting their spend as of January 1.   For others, the proposed delay  may be a welcome reprieve and an opportunity to prepare for compliance, now with the added benefit of the proposed rule.  Either way, Happy Holidays! 

The Supreme Court to Determine Whether Pharmaceutical Sales Representatives are Entitled to Overtime Pay

By: Sandra González

    Since our previous post, Should Sales Representatives Be Entitled to Overtime Pay?, we have continued to track the circuit split between the Second and Ninth Circuits on the issue of whether pharmaceutical sales representatives are entitled to overtime-pay.  The United States Court of Appeals for the Second Circuit found that sales representatives were not exempt from the Fair Labor Standards Act (“FLSA”) overtime-pay requirements, thus, they were entitled to overtime-pay.  In re Novartis Wage and Hour Litigation, 611 F.3d 141 (2d Cir. 2010).  However, the United States Court of Appeals for the Ninth Circuit ruled that pharmaceutical sales representatives are not entitled to overtime pay under FLSA.  Christopher v. SmithKlineBeecham Corp., 635 F.3d 383 (9th Cir. 2011).  Notably, two weeks after the Ninth Circuit decided Christopher, the Supreme Court denied review of the Second Circuit’s decision.  The Court’s denial of certiorari left many wondering about the repercussions that the circuit split would have on the industry.  Last month, PhRMA filed an amicus brief with the Supreme Court in which the organization requested review of the Ninth Circuit’s decision.  In that brief, PhRMA stated that “[u]ntil this circuit split is resolved, PhRMA members are exposed both to potentially staggering retrospective liability and to uncertainty over whether they must undertake major restructuring that would have significant consequences for the industry and its employees[.]”

On November 28, 2011, the Supreme Court agreed to review the Ninth Circuit’s case.  Upon review, the Supreme Court will examine two issues:  (1) whether deference is owed to the Secretary of the U.S. Department of Labor’s interpretation of the FLSA’s outside sales exemption and related regulations; and (2) whether the FLSA’s outside sales exemption applies to pharmaceutical sales representatives. 

Regarding  the first issue, the Department of Labor (“Department”) sided with the sales representatives in Christopher, stating that the outside sales exemption in the FLSA does not apply to pharmaceutical sales representatives.  Furthermore, in its brief to the Supreme Court, the Department stated that the Ninth Circuit’s opinion undermines “several decisions of the Supreme Court . . . instructing courts to defer to an agency’s interpretation of its own regulation unless ‘that interpretation is plainly erroneous or inconsistent with the regulation[.]’”  The Department argues that by denying deference to the Secretary’s interpretation, the Ninth Circuit has wrongfully expanded the definition of the outside sales exemption. 

The second issue will turn on the Supreme Court’s classification of the activities that pharmaceutical sales representatives engage in as “promotional” or as “making sales.”  If the Supreme Court rules that pharmaceutical sales representatives engage in promotional activities and do not “make sales,” the FLSA outside sales exemption would no longer apply and, absent application of another exemption, such as the administrative exemption, pharmaceutical companies would face multi-billion dollar repercussions. 

The Supreme Court will likely decide the issue in June of 2012.  Until then, we are left with a number of questions:  Why did the Supreme Court deny review of the Second Circuit’s decision, but grant review of the Ninth Circuit’s ruling?  Does the Supreme Court agree with the Second Circuit’s ruling?  If so, what are the implications for pharmaceutical companies?  Should companies start rethinking the industry’s current selling model and their current organizational structures? 

Zyrtec Went Viral on YouTube, Will Others Follow?

With the onset of the fall allergy season, Zyrtec made the bold decision to take its ad campaign viral with an interactive Choose-Your-Own-Adventure style video clip game, Parks Unleashed, on YouTube.  This was uncharted territory for both YouTube and the pharmaceutical marketing industry.  On September 5^th, Zyrtec launched its Parks Unleashed YouTube channel, which featured an interactive game based upon the premise of anthropomorphic dogs acting out the heist of stealing computer tablets from unsuspecting park visitors and burying those tablets throughout the park.  

 

The player was tasked with clicking on various screens and answering different questions, which led the player down different paths in search of the stolen tablets.  By clicking through the interactive game that includes talking dogs and quirky characters (Kyle the Krazy Kite King Guy, Roadie Rick, and Diamond Lady, to name a few), the player could earn a chance to win one of 200 Samsung Galaxy Tab Android tablet.  The game was available through the Zyrtec YouTube channel for about 6 weeks.  During that 6-week time period, the Parks Unleashed YouTube channel had more than 2.2 million views with each player spending an average of 7 minutes playing the game, and returning players spending as much as 30 minutes or more.  To date, the Parks Unleashed YouTube channel has had more than 2.6 million views.  McNeil Consumer Healthcare integrated its YouTube Zyrtec campaign with its branded website, used a Facebook ad campaign, and included a reference to its YouTube channel on one TV advertisement that ran for about one week.

 While Zyrtec is the first pharmaceutical company to utilize YouTube to advertise its product with an interactive game, Pepto Bismol also ventured into the YouTube social media advertising world around Cinco de Mayo this year by creating a YouTube app that allowed visitors to create their own “Pinata Smash” video and share their own video on Facebook or Twitter.

 The life science industry may be reluctant to charge forward and take full advantage of the advertising opportunities presented by social media based on the lack of specific guidance from FDA.  Typically, the life science industry will use its YouTube presence to post its television advertisements rather than create material specifically for YouTube, much less material that engages the user.  John Mack of the Pharma Marketing Blog is cited as stating that the lack of guidance from FDA is an easy excuse, but that is not the real problem.  According to Mr. Mack,  “What’s holding back the industry is the old axiom: You can’t teach an old dog new tricks…Social media is alien to both pharmaceutical marketers and corporate communications executives who are used to ‘pushing’ messages out to ‘targets’ rather than engaging in two-way communications with peers, which is the essence of social media.” 

 With both McNeil Consumer Healthcare and Proctor & Gamble dipping their toes into the social media water and using interactive social media to advertise over-the-counter pharmaceutical products, will we see other life science companies follow suit, take a risk and increase their use of social media to advertise their products, both over-the-counter and prescription?  Will the statistics of 2.2 million views in a 6-week time period be enough to convince the industry venture out of their advertising comfort zone and give social media a chance?

Supreme Court to Hear Cases on Health Care Reform Law

 

On November 14th, 2011, the Supreme Court announced in an order that it will hear arguments on three cases from the 11^th Circuit challenging the constitutionality of the Patient Protection and Affordable Care Act (“ACA”): National Federation of Independent Business v. Kathleen Sebelius, Secretary of Health and Human Services, et al.; Florida v. Department of Health and Human Services; and Department of Health and Human Services v. Florida.  The Court’s decision to hear these cases over the other health care appeals cases may be due to the involvement of more than half of the states and the inclusion of the most prominent legal questions raised about the legislation. 

 The Court will hear arguments on the following legal questions: 1) the constitutionality of the mandate that all Americans buy health insurance, 2) whether the insurance mandate, if deemed unconstitutional, is severable from ACA, allowing the remainder of the law to survive, 3) the legality of the expansion of Medicaid due to the potential coercive impact on states and whether such action exceeds Congress’s spending clause power, and 4) whether or not the Court has jurisdiction to hear this case in the absence of taxes being assessed and paid .

 The Obama administration has expressed its confidence in the survival of the health care reform law.  It is reported that Health and Human Services Secretary Kathleen Sebelius has stated, "We're very pleased that they have indeed decided to take the case…We're confident that the law is constitutional, will be upheld as constitutional."

 In the National Federation of Independant Business case before the Court, the 11^th Circuit found the individual mandate unconstitutional, but overturned the lower court’s decision and held that the individual mandate was severable from the remainder of the health care law.  For the life science industry, the issue of severability is of primary interest.  In the event the insurance mandate is determined to be unconstitutional and, secondarily, the mandate non-severable, it is a possibility that the entire healthcare law, including the sunshine provisions, might not survive.  We do not believe, however, that this is the expected outcome. 

 Come January 1^st, 2012, the life sciences industry will face requirements to begin capturing reportable data to comply with the Physician Payment Sunshine Act.  While the Centers for Medicare and Medicaid Services (“CMS”) submitted the draft regulations to the Office of Management and Budget for review on November 17^th, the life sciences industry still awaits an opportunity to view the draft regulations and the issuance of final regulations.  Yet, it does appear that CMS is making progress toward the release of final regulations.  Further, in the unlikely event that Court finds the individual mandate unconstitutional and  non- severable, does anyone believe that Senators Grassley and Kohl will give up the battle for transparency and disclosure? 

Ain’t No Sunshine in CMS’ Response

    By way of a scant, one-page letter dated October 28th, Centers for Medicare and Medicaid Services (“CMS”) finally issued a belated response to the letter co-signed by Senators Chuck Grassley (R-Iowa) and Herb Kohl (D-Wis.) that demanded answers from CMS for its failure to issue  the  Federal Physician Payment Sunshine Act (“Sunshine Act”) regulations by the October 1^st regulatory deadline.  (See prior post: “CMS Called to Task for Missing October 1st Deadline.”)  In addition to providing a tardy response, CMS Administrator, Donald M. Berwick, M.D., addressed CMS’ response letter solely to Senator Kohl stating that it would “also provide this response to the cosigner of your letter.”  Further, the letter provided limited information in response to demands set forth in the Senators initial demand letter. 

 CMS pointed to President Obama’s Executive Order 13563 to defend its delay in releasing the proposed regulations.  The January 18, 2011, Executive Order 13563 directed all Federal agencies to take steps to reduce regulatory burden.  CMS claims it is “carefully reviewing” the statutory requirements of the Sunshine Act  and “working hard” to implement the goals of the statute “while minimizing the burden on the regulated parties.”  Among other things, CMS’ letter fails to provide a timeline for its issuance of the Sunshine Act regulations or any details of CMS’ prior allegation that it submitted the proposed regulations to the Office of Management and Budget for review.  A large portion of CMS’ one-page response detailed the actions taken by CMS to “actively engage[]” stakeholders regarding CMS’ implementation of the Sunshine Act, which included one special Open Door Forum in March 2011, followed by one request for written feedback from participants of the same, and engaging others in the Health & Human Services Office of Inspector General for their input and assistance.

 The Senators released the following comments following receipt of CMS’ meager response:

 “The administrator’s response doesn’t tell us anything new.  There’s no explanation for the delay and no indication of when to expect completion.   It’s an inadequate response any way you look at it.  Meanwhile, the U.S. government just settled with a medical device maker for $2.4 million over allegations of kickbacks to doctors to use the company’s products.  The payments to doctors are the kind that might be prevented through disclosure as soon as the Sunshine Act is in place.  The longer we wait, the more taxpayers miss out on the benefits.   I’ll continue to press for answers from CMS.”

 -  Senator Chuck Grassley

 “Given how straightforward and detailed the Sunshine Act provisions were, it’s troubling that the response to our letter would come a month late without any indication on progress, a timeline or what caused the delay.  With medical device and pharmaceutical companies facing the January 1, 2012 deadline to begin collecting information about all payments to physicians, the lack of guidance leaves a great deal of uncertainty and I’m sure that’s why many of the affected companies have joined us in calling for swift implementation.”

 -  Senator Herb Kohl

 We continue to eagerly await much anticipated regulatory guidance from CMS.  And even without it, come January 1, 2012, life science companies will still be expected to begin capturing information for disclosure of interactions with physicians and teaching hospitals under the Sunshine Act.  Will CMS shock industry and issue regulations prior to January 1^st?  We will just have to wait and see…

FDA Blueprint: Gateway, Not a Barrier to Innovation

In our prior post, “Biotechnology Industry Pushing for Progressive Changes within FDA,” we discussed one industry group’s proposals for changes within FDA aimed at improving and expediting the drug and biologics approval process. This month, FDA Commissioner Margaret Hamburg outlined FDA’s blueprints for changes within FDA to encourage biomedical innovation as set forth in the document titled “Driving Biomedical Innovation: Initiatives to Improve Products for Patients."  This announcement follows an increase in criticism from lobbyists and political opposition regarding FDA’s approval process and burdensome regulatory process. According to FDA’s press release, Commissioner Hamburg stated, “America is at an important crossroads, where the science before us presents unprecedented opportunities to create new and better medical products and to promote better health for the public. Our innovation blueprint highlights some of the initiatives FDA will be implementing to ensure that these opportunities are translated into safe and effective treatments that can help keep both American patients and American industry healthy and strong.” Following public hearings and external meetings with stakeholders, FDA’s blueprint identifies the following seven areas for major action within FDA:

1. Rebuilding FDA’s small business outreach services;
2. Building the infrastructure to drive and support personalized medicine;
3. Creating a rapid drug development pathway for targeted therapies;
4. Harnessing the potential of data mining and information sharing, while maintaining strong privacy protections;
5. Increasing consistency and transparency in the medical device review process;
6. Training the next generation of innovators; and
7. Streamlining and reforming FDA regulations.

A number of FDA’s proposed major actions set forth mechanisms of change within FDA intended to lead to an improved and expedited approval process, specifically for personalized medicine, targeted therapies, and devices. To achieve this end, such proposed changes include clarification of agency policies, streamlining the necessary coordination between Centers, and improving transparency and predictability within FDA. To create a rapid drug development pathway for targeted therapies, FDA proposes to host a series of scientific meetings with stakeholders and develop draft guidance on an expedited development pathway. From the outside looking in, FDA’s blueprint is a great starting point, but does not include many, if any, ground shifting methodologies that will initiate significant change within FDA on an expedited basis. However, maybe the changes that need to be made within FDA are fundamental regulatory shifts rather than reinventing the process.

While FDA’s announcement is timely and likely well received amidst industry concerns of regulatory burdens to obtaining approvals of new drugs and the growing chorus of Americans disgruntled about the loss of jobs to outsourcing and the stalled economy, the success of FDA’s blueprint will be determined by whether FDA effectively implements these initiatives and industry and the public sees tangible results. In a post on the White House Blog, Vicki Seyfert-Margolis, Senior Advisor for Science Innovation and Policy for the FDA’s Commissioner’s Office, referred to FDA’s blueprint as “a productive and important first step toward smart innovation-focused reform at FDA.” If this innovative-driven reform is successful as a first-step in putting true change into motion, industry can hope to see a less burdensome approval process resulting in an increase in America’s life science development pipeline and innovative advances from start-up life science companies.