Who Wants a Strong FDA?

Written by Jonathan Wozniak - Validation Specialist, QPharma

Last Valentine’s Day (14 Feb 2011) saw the release of the United States Federal Budget for Fiscal Year (FY) 2012.  Included in this was a $4.4 billion budget request for the FDA.  This request represents an increase of approximately $1billion or 33% since 2010.  Budget proposals include increased investment in food safety initiatives, medical product safety, and regulatory science.  This announcement came mere days after House Republicans unveiled a spending bill that included a $241 million cut to FDA funding for the remainder of FY2011 as part of a $100 billion overall spending cut package.  The case for or against a strong FDA, however, does not divide clearly down party lines.  As professionals in an industry directly regulated, guided, and affected by the strength of the FDA, we are right to wonder:  who wants a strong FDA?

In March 2011, the Alliance for a Stronger FDA (an “alliance of patient groups, consumer advocates, biomedical research advocates, health professionals, and trade associations”) released a white paper entitled “The U.S. Food and Drug Administration: A Cornerstone of America’s Economic Future.”  (http://fdaalliance.files.wordpress.com/2009/11/fda_cornerstone_of_american_economy_final.pdf) 

In this report, the Alliance outlines a number of ways in which the FDA is critical to the future of economic growth.  The first main argument put forth in the paper is, roughly, this: 

1. A strong FDA increases the safety and effectiveness of drugs and medical devices.
2. Increased safety and effectiveness of drugs and medical devices increases consumer confidence.
3. Increased consumer confidence fuels the industry; people buy more products from an industry they trust. 

The second argument suggests that a better-funded FDA will have more, better-trained employees (the FY2012 Budget Request claims 1,251 new employees could be hired).  This will expedite approval times and increase the frequency and effectiveness of inspections.  For example, the FDA has a two year backlog of generic drug applications due to funding restraints.  Better FDA funding means more employees tackling this paperwork.  This could result in an increased availability of generic drugs, which saves the consumer money and decreases overall health care spending in America.  The Healthcare Reform Act passed last year (H.R. 3590) also included a provision to remove the cap on members of the National Health Service Officer Corp and increase the National Health Service Corp budget by over $8 billion between 2010 and 2016.  This would increase the size and reach of the American public health response, but the program- like most current spending initiatives- is now in question.  The Alliance also points to the potential consequences of a weakened FDA, namely the increased potential for food borne illness outbreaks and increased frequency of drug and device recalls.

The FDA makes a number of strong claims to its effectiveness and importance: it creates jobs, increases safety and effectiveness of drugs and devices, increases consumer confidence fueling industry growth, and reduces health care costs.

However, the FDA is not without its critics.  There are many who believe the FDA is actually too strong, as it is.  The first major criticism is that raised by Republican spending cuts:  people everywhere have to tighten their belts in difficult economic times; the government should have to do the same.  Increases in FDA funding are not necessary, critics claim, because the system works fine as it is.  Increased spending on food safety is unnecessary as food borne illnesses are rare.  This is, generally speaking, the argument that a strong FDA costs too much.  Rep. Jack Kingston, Chairman of the House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, commented after the passage of the Food Safety Bill in January, “There is a high possibility of trimming this whole package back… the system we have is doing a darn good job.”  He also noted our food safety rate is “very high, 99.99% safe”.  (http://www.foodsafetynews.com/2011/01/fda-food-safety-funding-still-on-chopping-block/)

The second major criticism of a strong FDA is that industry growth is actually stifled.  There were only 21 new drugs approved in 2010 (by 21 separate companies).  Extra clinical trials, extended review processes, and comparative effectiveness studies are just a few of the measures implemented by the FDA that actually deter companies from new product development.  The measures designed to increase safety and improve patient outcomes inherently delay approvals, and these delays cost time, money, and lives.  The potential stagnation of innovation in the industry creates opportunities for foreign markets to catch up to the American pharmaceutical and medical device industries moving jobs and revenue overseas. 

Meanwhile, FDA faces major statutory initiatives to introduce generic biologics and to require premarket clearance of tobacco products; lack of sufficient personnel to execute these programs could result in their getting shelved, or alternatively, firms facing endless delays; these two alternatives will definitely make some people happier than others, but will increase uncertainty no matter who winds up the winner.

So where should we stand?  As professionals in the industry it remains hard to say and might actually vary depending where we work.  Drug and device makers might appreciate a weakened FDA in the short term.  Inspections, warning letters, and sanctions would be fewer and farther between.  Pre-market approval processes could be restructured to facilitate new product release.  Drugs not subject to strict comparative effectiveness studies will remain on the market longer.  These parties, however, should not forget that approvals may take longer in an understaffed agency, and the potential for recalls increases with an expedited approval process.  (http://www.latimes.com/health/la-na-medical-devices-20110215,0,4206876.story) 

As a consulting firm dealing largely in compliance and regulation, it would seem on the surface that a more active and involved FDA would create more work for us.  The more inspections, rulings, warning letters, and white papers- the more work there is for us helping our clients comply.  We would not be shortsighted, however, and ignore the possibility that a strengthened FDA could stifle industry.  After all, a company not making money is not hiring consultants. 

As experts in industry, we have a responsibility to keep an eye on the strength of the FDA – especially in a time of complicated economic turmoil and incremental health care overhaul.  We can help our companies position themselves better for change when we are able to anticipate shifts in the strength of the FDA as a regulating body and what they will mean for industry.  A large part of our doing business—from staffing, to setting rates, to training—depends on where and how we anticipate the FDA to act; while the strength of the FDA, predicated by its funding and staffing, largely determines its reach and impact.

Purchasing Medications Online

Written by Teresa Jaworski - Subject Matter Expert, QPharma

Using the Internet to purchase items has become a very popular and convenient way of acquiring things we need without leaving the comfort of our homes.  In addition, the Internet allows us to browse many different websites quickly so that we can compare costs and buy products at the most affordable prices.

However, when purchasing medications online, we should be very cautious.  You could purchase a drug that is not safe and put your health at risk.  Many websites that sell medications online are not US state-licensed pharmacies or are not pharmacies at all.  Therefore you run the risk of purchasing counterfeit medicines that contain dangerous ingredients; are not manufactured according to standards; contain the incorrect dosage of ingredients; are contaminated; are not labeled, stored or shipped properly; or have expired.  Counterfeit drugs are illegal!

The FDA issued a draft guidance document dated July 2009, Draft Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting, which will provide guidance for pharmaceutical manufacturers in using inks, pigments, flavors, and other physical-chemical identifiers (PCIDs) when making a drug product in solid oral dosage forms.  The use of PCIDs will make it more difficult to counterfeit a drug thus making it easier to identify a genuine version of the drug.  According to an FDA News Release dated July 13, 2009, “Drug counterfeiting is a serious public health concern,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D.  “We look forward to working with industry to help ensure that consumers are not exposed to products containing unknown, ineffective, or harmful ingredients.”

A PCID is a substance or combination of substances with a unique physical or chemical property used to identify and validate a drug product.  According to FDA, a substance used as a PCID should not adversely affect the identity, strength, quality, purity, potency, or bioavailability of the drug product.  The PCID can often be detected by wholesalers or pharmacists however, in some cases an analytical instrument may be necessary to detect the PCID in order to determine if the drug products are genuine.

The FDA expects that most of the impending PCID ingredients are already being used as food additives, colorants, or other types of inactive ingredients and have already been established as safe.  FDA recommends using the lowest amount of PCID that allows for identification of the product and recommends that the PCID be a substance with no medicinal effect.  Refer to the draft guidance document located at www.fda.gov for additional information.

In a recent FDA News Release, the FDA warned consumers about a potentially harmful product, “Generic Tamiflu.  The product did not contain Tamiflu’s active ingredient, Oseltamivir, but Cloxacillin, an ingredient in the same class of antibiotics as Penicillin.”   FDA warned that using this product could result in an allergic reaction for patients that are allergic to penicillin including “a sudden, potentially life-threatening reaction called anaphylaxis, with symptoms that include difficulty breathing, chest tightness, swelling of the throat or tongue, hives, dizziness, loss of consciousness, or a rapid or weak pulse.”

Upon learning of the so called “Generic Tamiflu”, FDA purchased a package of the product without a prescription from a website that claimed to be an online drugstore.  The “Generic Tamiflu” was received in a postmarked package from India.  The product was stored in two blister packages with foil-backing labeled “Oseltamivir Phosphate 75mg. Capsules TM-FLU Capsules” and “Manufactured by: TRYDRUGS Pharmaceuticals PVT. LTD.”  An FDA-approved generic drug for the prescription drug “Tamiflu” does not exist.

In another FDA News Release, dated January 25, 2010, the FDA warned consumers about a counterfeit version of the weight-loss drug Alli being sold at online auction sites over the Internet.  FDA indicated that this counterfeit product was unsafe and illegal.  “Alli is an FDA-approved, over-the-counter weight-loss drug that contains Orlistat as its active ingredient. The counterfeit version of Alli does not contain Orlistat; instead it is made with varying amounts of Sibutramine, a stimulant drug.”  Laboratory testing completed by FDA determined that the dosing directions specified a dosage of three times the usual daily dose of Sibutramine, which could result in elevated blood pressure, stroke, and heart attack for people with a history of cardiovascular disease.  Additionally, healthy people taking this product could suffer anxiety, nausea, heart palpitations, racing heart, insomnia, and small increases in blood pressure.

FDA continuously monitors the Internet and even makes purchases so they can test the drug products to verify product authenticity.  However, consumers need to protect themselves as well by knowing how to recognize a genuine internet pharmacy.  A genuine internet pharmacy will be licensed by the U.S. Board of Pharmacy and will follow the relevant laws and regulations.  In addition, the National Association of Boards of Pharmacy Verified Internet Pharmacy Sites Seal (VIPPS Seal) provides a seal of approval to pharmacy sites that meet state license requirements.  A pharmacy that carries this seal can be found at www.vipps.info.

OBAMACARE and INDUSTRY Part II

Written by Jeff Boatman - Senior Subject Matter Expert, QPharma
As promised continued from OBAMACARE and INDUSTRY Part I 

Title VII, Improving Access to Innovative Medical Therapies

Section 7002 could wind up being the “sleeper” of the new law: it establishes rules for biosimilar biological entities...in essence, generic biologics.  Even after a biologics patent runs out, it is in many instances theoretically impossible for a competitor to produce an absolutely identical copy (many of these products come from unique cell lines, for example), so FDA has been charged with coming up with criteria for considering a “copy” to be “close enough.” In principles, this is really nothing new: generic drugs do not have to be identical to the original drug they are based on, and in fact can be quite different in composition and manufacture.

This new provision is in response to FDA’s testimony before Congress that existing laws do not permit licensing of biosimilars, while the Europeans have been moving ahead in this area. Congress is fully aware of how competitive—and litigious—this industry is: more than half of this lengthy section deals with detailed rules for patent exclusivity!  The law requires a report to Congress in January 2012 on recommendations, and Congress is required to then establish (through separate legislation) a user fee program...so don’t expect any biosimilar products to be on the U.S. market any time soon.

Title IX, Revenue Provisions

Speaking of user fees: drug manufacturers and importers have long been paying to register their facilities and market their drugs. The Medical Device world has largely avoided this (I used to recommend that my Medical Device clients ignore FDA’s “30 days before commercial distribution” regulation and just register their facility as soon as possible “because, after all, it’s free”); but in recent years, that has changed as well.

Usually, companies know in advance how much they have to pay FDA for the privilege of staying in business because Congress would pass a clearly identifiable law with the words “user fee” in the title: the FDA Modernization and User Fee Act, the Prescription Drug User Fee Act, etc. Well, if you can’t find the latest round, it doesn’t mean you no longer have to pay the government...it just means that this information is buried inside the healthcare reform bill.

Branded prescription drug fees are covered in Section 9008; sales less than five million dollars are exempt and orphan drugs are excluded. Medical device fees are discussed in Section 9009, with exemptions for Class I and certain Class II devices (under $100 retail). Companies with less than five million dollars in sales are excluded.

If you are looking for the exact dollar amount you need to write a check for, you will be disappointed; the section only explains how the fee will be calculated. You’ll still need to keep an eye on fda.gov and pay the amount the Agency subsequently publishes.

Title X, Strengthening Quality, Affordable Health Care for All Americans

Note: don’t get fooled by the fancy title – this is just where Congress dumped all the amendments that were added after the main bill was adopted

Section 10608 adds some minor tweaks to the ANDA process, clarifying that the generic drug’s submitted labeling need not be identical to the original when the text changes result from 21 CFR 355(i) (in other words, clinical research), so long as the “Warnings” section remains the same and there are no remaining patent conflicts. FDA has 60 days to review the new labeling and demand revisions; the Agency can then choose to deny the ANDA on the basis that the final submitted labeling impacts safe use.

Confused? Me too; expect guidance on this from FDA in the future.

MISCELLANEOUS UNRELATED ITEMS

So that’s my list of items in the healthcare bill that impact our industry. If you saw something else, or if I got something wrong (entirely possible considering how complicated the Act is) or just want to let us know your opinion, please post a comment!

Meanwhile, here are a couple of interesting items I came across in my reading.
 

• Do you know any cosmetic surgeons? Section 9017 changes the Internal Revenue Code to require doctors to collect a 5% federal excise tax on cosmetic procedures.
   
• Senior citizen with unreimbursed medical bills? Section 9013 decreases the threshold for deducting medical expenses from the current 10% of income down to 7.5% – but only if you or your spouse are over 65, and only from 2013 through 2016.
   
• Are you a high earner? You’ll be seeing a non-deductible FICA “hospital” tax equaling 0.5% of all income above $200,000.
   
• Enjoying your winter tan? Section 10907 is an amendment that imposes a 10% excise tax on non-medical tanning procedures.  The amendment also nullifies a pertinent section of the Internal revenue Code, so I don’t know if this is a completely new tax or just an increase.

• Finally, you have no doubt heard about the provisions in Section 4205, requiring chain restaurants and vending machine operators with more than twenty stores or machines to post full nutritional information, including on signs at drive-throughs and on the sides or near vending machines (I won’t comment on the practicality of that last one).  But the law then goes on to inform owners of less than twenty restaurants and vending machines that even if they aren’t legally required to post nutritional information under the Act, they can voluntarily comply...by registering with FDA! So: if the owner of a diner decides to tell customers how many calories are in that hamburger but doesn’t first register with FDA, is he committing a federal crime? Or on a more serious note, what about municipalities that mandate posting of nutritional information at restaurants within their jurisdiction? Does that now mean the chain must also register with FDA, even if only 15 restaurants (to use New York City’s rules as an example) are within the city limits?