Today, I gave a webinar presentation with Ken Phelps, President of Camargo Pharmaceutical Services, on the interaction of patents and exclusivity of drugs approved by the FDA under section 505(b)(2). Ken is an expert at 505(b)(2) filings so my job (covering patent issues) was pretty easy.

Ken notes that large pharma and small start-ups alike are keenly interested in these filings with no signs of letting up. It’s not hard to see why. Section section 505(b)(2) drug applications find a unique (although often neglected) place between innovative drug NDAs and and the generic ANDAs.

Section 505 of the Federal Food, Drug, and Cosmetic Act describes three basic types of new drug applications:

1. an application that contains full investigations of safety and effectiveness (section 505(b)(1));
2. an application that contains full investigations of safety and effectiveness but where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference (section 505(b)(2)); and
3. an application that contains information to show that the proposed product is identical in active ingredient, dosage form, strength, route of administration, labeling, quality, performance characteristics, and intended use, among other things, to a previously approved product (section 505(j)).

An important benefit of 505(b)(2) applications compared to Abbreviated New Drug Applications (ANDAs) is the ability to earn market exclusivity. Like ANDAs, 505(b)(2) submissions must include all relevant patents and patent certifications and are subject to the same Paragraph IV challenges and litigation, including a 30-month stay. However, 180-day exclusivity is not granted.

So, what type of information can an applicant rely on?

1. Published literature (a literature-based 505(b)(2)). If the applicant has not obtained a right of reference to the raw data underlying the published study or studies, the application is a 505(b)(2) application; if the applicant obtains a right of reference to the raw data, the application may be a full NDA (i.e., one submitted under section 505(b)(1)).

2. The Agency’s finding of safety and effectiveness for an approved drug to the extent such reliance would be permitted under the generic drug approval provisions at section 505(j). This approach is intended to encourage innovation in drug development without requiring duplicative studies to demonstrate what is already known about a drug while protecting the patent and exclusivity rights for the approved drug.

What kind of application can be submitted as a 505(b)(2) application? The applications are for either (a) new chemical entity (NCE)/new molecular entity (NME) or (b) changes to previously approved drugs — changes of the type described immediately below may not require review of information other than BA or BE studies or data from limited confirmatory testing:

• Dosage form
• Strength
• Route of administration
• Substitution of an active ingredient in a combination product.
• Formulation
• Dosing regimen
• Active ingredient, e.g., a different salt, ester, complex, chelate, clathrate, racemate, or enantiomer of an active ingredient in a listed drug containing the same active moiety.
• New molecular entity, often a prodrug of an approved drug or the active metabolite of an approved drug
• Combination product
• Indication
• Rx/OTC switch
• OTC monograph
• Naturally derived or recombinant active ingredient
• Bioinequivalence, where absorption is different from the 505(j) standards

You cannot submit an application that is a duplicate of a listed drug and eligible for approval under section 505(j) or submit an application where the only difference is the extent to which the active ingredient(s) is absorbed or otherwise made available to the site of action is less than the listed drug.

Why is all this trouble worth it? In a word: Exclusivity. A 505(b)(2) application may obtain 3 years of Waxman-Hatch exclusivity if one or more of the clinical investigations, other than BA/BE studies, was essential to approval of the application and was conducted or sponsored by the applicant.  An applicant can get 5 years of exclusivity if it is for a new chemical entity.  A 505(b)(2) application may also be eligible for orphan drug exclusivity or pediatric exclusivity.

Approval or filing of a 505(b)(2) application, like a 505(j) application, may be delayed because of patent and exclusivity rights that apply to the listed drug.  This is the case even if the application also includes clinical investigations supporting approval of the application.

The 505(b)(2) application requires applicant to file patent certifications with application and serve notice on NDA holder and patent owner. This patent information will be published in the Orange Book when the application is approved. The types of filings include:

1. Paragraph (I): no patent was listed in Orange Book
2. Paragraph (II): listed patent has expired
3. Paragraph (III): listed patent will expire before requestedapproval
4. Paragraph (IV): listed patent is invalid or will not be infringed

The great thing about this is, if approved, is that the applicant will enjoy complete exclusivity. If the approval is for a new chemical entity (NCE), the exclusivity prohibits a generic manufacturer from submitting an ANDA for 5 years from date of NDA approval. Although, if an ANDA includes a paragraph IV certification, an ANDA can be filed after 4 years, but any 30-month stay is extended by up to 1 year (to expire 7-1/2 years after NDA approval).

An application for new clinical indications for approved products receive three years of exlusivity. This exclusivity prohibits FDA approval (but not submission) of an ANDA for 3 years after NDA/sNDA approval. Therefore, ANDA approval can come exactly 3 years later.

The period of time of exclusive marketing rights is granted by FDA at the time of approval and cannot be challenged or voided. The time runs from the date of approval, except for pediatric exclusivity, which attaches to an existing exclusivity or patent period.

All this and patent protection may apply also. What’s not to love?

Posted April 22nd, 2008 by Stephen Albainy-Jenei in Generic drugs, FDA
| | 1 Comment »

Eighteen states and the District of Columbia have filed suit against Abbott Laboratories and Solvay’s Fournier Industrie et Santé and Laboratories Fournier for allegedly entering into a scheme to block the generic version of the cholesterol lowering drug TriCor®  (fenofibrate), indicated for the treatment of hypercholesterolemia and hypertriglyceridemia.

According to the AGs in the states, the companies made trivial changes to the formulations of TriCor, and marketed those while withdrawing the original drug from the market. The companies deleted references to the original forms of the drug from national drug databases, according to prosecutors, making it more difficult for a generic version of TriCor to obtain generic status

The states filed their lawsuit in federal court in Wilmington, Delaware, accusing Abbott and of undermining efforts to bring generic drugs to market by patenting new formulations of TriCor with only minor changes to the drug.

TriCor, which costs more than $3 a pill, generated sales of $1.2 billion for Abbott in 2007, but the company, according to the lawsuit, has tried to maintain a monopoly on the market by obtaining term-extending patents. Abbott denies the allegations saying it has not prevented other fenofibrate drugs from being marketed.

The prosecutors say Fournier obtained patents covering the variations of TriCor and then filed patent infringement lawsuits against generic companies that tried to compete. The litigation meant that the Food and Drug Administration could not approve generic versions of TriCor.

In a long-running battle with Teva Pharmaceutical, Abbott has tried to stay one step ahead of the generic entry. Originally, Teva filed an ANDA for ANDA for a TriCor capsule formulation and made a Paragraph IV certification that U.S. Pat. No. 4,895,726 was invalid so not infringed. A bbott sued and initiated a 30-month stay of FDA approval.

While the capsule battle was continuing, Abbott filed a new NDA for 54 mg and 160 mg TriCor in a tablet formulation arguing that the tablet was bioequivalent to the capsule. After this was approved, Abbott stop selling the capsules and bought back all the capsules from the market.

The Abbott, in a move that was probably too smart for their own good, changed the code for TriCor capsules in the National Drug Data File (NDDF) to “obsolete.” The NDDF is a private database that provides information about FDA-approved drugs. Changing the code to obsolete then removed the TriCor capsule drug formulation from the NDDF, which prevented pharmacies from filling TriCor prescriptions with a generic capsule formulation.

Needless to say, Teva took it kind of hard and added antitrust counterclaims to its suit against Abbott. Abbott is no longer marketing the 54 mg and 160 mg strength tablets because it has now changed its Tricor product to 48 mg and 145 mg strength tablets. Abbott even filed a new NDA for 48 mg and 145 mg TriCor tablets looking to change the label to state that the new tablets do not need to be taken with food (the dissolvable version).

Teva claims that Abbott’s actions have frustrated generic competition in Fenofibrate products through a combination of two market conversions and the gaming of the Hatch-Waxman Act, denying consumers access to a generic alternative to Abbott’s products.

The dissolvable version of TriCor retains patent protection until 2018.

In the current suit by various AGs, the states involved are Arizona, Arkansas, California, Connecticut, the District of Columbia, Florida, Iowa, Kansas, Maine, Maryland, Minnesota, Missouri, Nevada, New York, Oregon, Pennsylvania, South Carolina, Washington, and West Virginia.

No word yet on when Abbott’s new magic orange-colored TriCor comes out.

See a timeline at the Orange Book blog.

Posted March 21st, 2008 by Stephen Albainy-Jenei in Generic drugs, FDA, IP Litigation
| | 5 Comments »

What happens when a brand name drug company asserts that a patent covers its drug and then pulls it out from the Orange Book? You fight to get it back in, that’s what.

In August, Teva Pharmaceuticals USA submitted a Citizen Petition pursuant to section 505 of the Food, Drug, and Cosmetic Act (FDCA) asking the FDA to do just that.

The FDA’s official Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book“) listed two patents as claiming Risperdal® tablets: U.S. Patent No. 4,804,663, which was set to expire on December 29, 2007, and U.S. Patent No. 5,158,952 (”the ‘952 patent”), which will expire on October 27, 2009.  Risperidone is an antipsychotic medication sold by Janssen Pharmaceutica (a subsidiary of Johnson & Johnson) under the trade-name Risperdal®.

Teva submitted an original Abbreviated New Drug Application (ANDA) seeking approval to market generic risperidone tablets. Because the Orange Book listed both the ‘663 and ‘952 patents for Risperdal® tablets, Teva was required to certify as to both patents.

Teva filed a certification under § 355(j)(2)(A)(vii)(III) (”Paragraph III certification”) as to the ‘663 patent, which is set to expire on December 29, 2007, and a certification under § 355(j)(2)(A)(vii)(IV) (”Paragraph IV certification”) as to the ‘952 patent, asserting that the patent was invalid or would not be infringed by Teva’s generic risperidone tablets.

Ordinarily, Teva would be entitled to 180 days of marketing exclusivity for its generic risperidone tablets as a result of its paragraph IV certification to the ‘952 patent. That’s because the ‘952 patent appeared in the official Orange Book when it originally filed – that meant that Teva was required to submit a certification to that patent at the time it submitted its ANDA for generic risperidone drug products. Teva then became the first company to submit a paragraph IV certification to any of the listed patents claiming Risperdal®.

On October 12, 2001, FDA notified Teva that it had “delisted” the ‘952 patent from the Orange Book (even though it continued to appear in the official Orange Book at that time) It also informed Teva that it would not accept Teva’s ANDA for filing unless Teva modified its patent certification to reflect that the ‘952 patent was no longer listed as claiming the reference drug product.

In November 2006, the D.C. Circuit ruled that the plain text of the FDCA prevented the FDA from effectuating the delisting of a patent following the submission of a paragraph IV certification as to that patent. Ranbaxy Laboratories Ltd. v. Leavitt, 469 F.3d 120, 125-26 (D.C. Cir. 2006). The court struck down the FDA’s practice because it “changed the incentive structure adopted by Congress,” by “depriving the generic applicant of a period of marketing exclusivity” after the generic manufacturer had expended significant resources in developing a non-infringing generic substitute and undertaken the risk of infringing the patent by filing a paragraph IV certification.

Teva then filed a Citizen’s Petition with the FDA arguing that the FDCA entitles Teva to a 180-day period of first-filer exclusivity for generic Risperdal® tablets since it was the first generic manufacturer to file an ANDA for generic risperidone tablets containing a paragraph IV certification as to the ‘952 patent.

Under 21 U.S.C. § 355(j)(5)(B)(iv) (2002), the earliest any subsequently-filed paragraph IV ANDA can be approved is “one hundred and eighty days after” Teva first commercially markets its generic risperidone tablets or the date of a court decision holding the ‘952 patent to be invalid or not infringed.

Teva argued that both FDA regulations and case law make clear that the agency does not adjudicate questions of patent law; instead, it plays only a ministerial role in maintaining the Orange Book. As a result, where a patent remains listed for a particular drug in the official Orange Book, a generic applicant has no choice but to believe that the NDA holder is continuing to assert that patent as claiming the listed drug.

Thus, at the time of its ANDA submission in August 2001, Teva was required to submit a certification to the ‘952 patent. Teva now wants its 180-exclusivity for these drug products.

The question here is whether or not a brand manufacturer can game the system by delisting a patent after the submission of a paragraph IV certification and without notice, forcing generic manufacturers to invest resources and assume the risk of patent litigation without any guarantee of the 180-day exclusivity reward.

The FDA wrote back a nice note to Teva:

We have carefully reviewed your Petition and have concluded that the ‘952 patent was delisted before Teva submitted ANDA 76-228 to FDA. For the reasons described in further detail in this Response, we deny your request that FDA relist the ‘952 patent. As Teva’s ANDA did not contain a paragraph IV certification for a listed patent, and Teva did not provide the required notice of such certification to the holder of the NDA for the reference listed drug and each owner of the listed patent, Teva would not be eligible for 180-day exclusivity pursuant to section 505(j)(5)(B)(iv) of the Act for its pending ANDA 76-228.

Like a game of Calvinball*, since the FDA had itself forced Teva to remove the paragraph IV certification or it wouldn’t accept the ANDA, the FDA now claims that Teva’s out of luck because it did, in fact, take out the certification.

Nice.

It probably wouldn’t take a law degree to guess that Teva has filed a lawsuit in federal court to try to get the Petition granted. Johnson & Johnson’s sales of antipsychotics in the U.S. were more than $2.7 billion last year with Risperdal accounting for a large part of that amount. A generic can make quite a bit in just 180 days.

Stay tuned.

Teva vs. FDA Complaint

[*Note: Under the Official Rules of Calvinball, Rule 1.2. states: “Any player may declare a new rule at any point in the game (Figure 1.2). The player may do this audibly or silently depending on what zone (Refer to Rule 1.5) the player is in.”]

Posted March 7th, 2008 by Stephen Albainy-Jenei in Pharmaceutical, Generic drugs, FDA, IP Litigation
| | 3 Comments »

At the beginning of the last century, the majority of drug products available were ineffective for their stated purpose at best and worsened the conditions they were purported to cure at worse.  For many of these so-called Patent Medicines, the main active ingredient was a form of alcohol (in the case of the Toneco Bitters bottle above, 30% according the lower label).

Note:  Few if any of the elixers were actually patented — these were medicines with trademarks, not patented medicines.  The phrase patent medicine comes from the late 17th century marketing of medical elixirs, when some were issued letters patent authorizing use of a royal endorsement in advertising.

A series of articles in Collier’s magazine, published in 1905-06, began with these words:

Gullible America will spend this year some seventy-five millions of dollars in the purchase of patent medicines.  In consideration of this sum it will swallow huge quantities of alcohol, an appalling amount of opiates and narcotics, a wide assortment of varied drugs ranging from powerful and dangerous heart depressants to insidious liver stimulants; and, far in excess of all other ingredients, undiluted fraud.

Samuel Hopkins Adams, The Great American Fraud 36 COLLIER’S 14 (Oct. 7, 1905).

This series of articles contributed to the pressures to enact laws regulating the food and drug industries, ultimately resulting in the Federal Food, Drug, and Cosmetics Act (FD&C Act).

Since 1962, before a new drug can be marketed in the US, the Food and Drug Administration (FDA) must approve it, after it is shown to be safe and effective. This has not been without side-effects since the FDA requirement that a new drug is safe and effective, which ordinarily means that a company must complete clinical trials, which increased the cost of developing new drugs and delays their introduction.

According to conventional wisdom, the cost and delay involved in this process lessens incentives to invest in the development of new drugs.  Accordingly, several reforms aimed at restoring such incentives have been implemented and many others have been advocated.

One way that drug companies are compensated for the regulatory burden is the extension of patent terms. In the US, the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act) makes it possible for drug patentees to have the term of their patent extended for as much as five years if they meet certain criteria.  In the EU, there is the Supplementary Protection Certificate (SPC).

Ariel Katz, Assistant Professor at the University of Toronto, has now published a paper looking at some of the effects of regulation in the drug industry entitled “Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry.”

This paper looks at the argument that drug regulation and drug innovation are at odds with each other and shows that the regulatory framework is not solely a burden imposed on the industry; it also provides a valuable service to the industry, that is, drug regulation provides certification of drug quality.  This certification contributes to the value of new drugs and may actually encourage innovation.

Prof. Katz now challenges the argument that new drug regulation negatively affects the incentives for new drug innovation. It’s good food for thought on the ripple effects of drug regulations.

This paper, published in 14 Michigan Telecommunications and Technology Law Review, can be downloaded without charge at the Social Science Research Network Electronic Paper Collection.

[Side note:  Some consumer products were once marketed as patent medicines but have been reformulated and are no longer sold for medicinal purposes. Their original ingredients may have been changed to remove drugs, such is the case with Coca-Cola®.  Others, like Vicks VapoRub® still exist.]

Posted March 4th, 2008 by Stephen Albainy-Jenei in Pharmaceutical, FDA
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Robert Shapiro, chairman of Sonecon, LLC, and former advisor to U.S. President Bill Clinton and British Prime Minister Tony Blair, has published a study on the potential savings when generic biologic treatments (biogenerics) find a pathway in the U.S.   I say when and not if since the government is the largest consumer of medical care via medicare and medicaid and given the fact that sales of biotech drugs were $40.3 billion last year.

With such enormous amounts of money involved, Congress is seriously interested in creating a new regulatory pathway for the approval and marketing of generic or follow-on versions of biological treatments that no longer have patent protection. This is purely an economic (and political) issue, not one of health and safety.  Today, more than 150 biopharmaceuticals are available in the United States, including therapeutic serums, antitoxins, vaccines and biological therapeutics that induce immunity in infectious diseases, and the number of new biologics is growing at twice the rate of new small molecule pharmaceuticals.

Under the Hatch-Waxman Act, a pharmaceutical producer can secure FDA approval to market a generic version of an original drug no longer under patent protection without having to conduct lengthy and expensive safety and effectiveness studies and clinical trials, by demonstrating that the generic is the bioequivalent of the original drug. The process involves the approval of an Abbreviated New Drug Application (ANDA), which rests on a certification that the original patent has expired or is invalid, and that the dosage and active ingredients of a generic are identical to those in the original treatment.

However, the law covers only traditional, small-molecule pharmaceuticals. There is no mechanism for generic-drug makers to gain approval for generic biotech drugs or so-called follow-on biologics, sometimes called biosimilars or biogenerics.  The FDA evaluates and approves biologics mainly under the Public Health Safety Act, although a small number have been approved under the Food, Drugs and Cosmetic Act. The Center for Biologics Evaluation and Research (CBER) regulates biological products for safety. For the FDA to approve follow-on biologics, many difficult issues have to first be addressed such as safety, effectiveness and intellectual property rights have to be resolved.

The reason for the lack of a regulatory pathway for approval of biogenerics lies in the complexity of the biological products themselves. Biologics are large, complex, heterogeneous molecules for which the manufacturing process can be a determinant of the end product. Demonstrating that a generic version of the product is as safe and effective as the brand name product would be a difficult at best since, for example, establishing that immunogenicity had not been altered and that any undetected differences in the product would not impact safety and efficacy would be problematic without conducting extensive clinical trials.

Currently, the cost of conducting clinical studies from scratch keeps competitors out of the market. Biogeneric companies need an abbreviated approval pathway to avoid undertaking the same large scale clinical development process as the originator companies, and thus allow them to market their product at a discount to the brand while maintaining a profit margin.

It is likely that any follow-on biologic applicant would be required to demonstrate that there are no clinically meaningful differences in safety, purity and potency between its product and the brand product. An applicant would need to provide evidence that its product has profound similarity — it is impractical to show identical biological products — and that these will produce the same clinical result as the brand product in any given patient and that it presents no additional safety risks or diminished efficacy if a patient alternates or is switched between products.

During a conference call this morning, Shapiro noted that the conventional wisdom held that the high cost of building the manufacturing infrastructure would be so high as to result in very little savings even if biogenerics are allowed. He argues that this is not the case given that there are plenty of other options in the marketplace. Shapiro pointed out the facilities currently available in Europe and Asia and the potential for partnerships.

According to the present study, the potential savings likely to follow from the introduction of these follow-on biologics over the next 10 and 20 years would be quite large. The study found that generic versions of the top 12 categories of biologic treatments with patent protections that have expired or are due to expire in the near future could save Americans, in net present value, $67 billion to $108 billion over the first 10 years and $236 billion to $378 billion over 20 years. Moreover, these estimates almost certainly understate the savings, because they could not take full account of a number of factors likely to reduce the price of biogenerics and further expand their use in the United States.

Currently, biogenerics are used in the European Union and the major countries of Asia. The study concludes that the United States has led the world in developing biologics, and when the U.S. Congress approves a regulatory pathway for biogenerics, the United States very likely will quickly become the world’s largest market for follow-on biologics.

See the entire report here.

See also:  Why are biogenerics so hard to regulate?

More from the Orange Book Blog and the BioJobBlog.

Posted February 19th, 2008 by Stephen Albainy-Jenei in Biogenerics, FDA, Biotech News
| | 3 Comments »

Rep. Henry Waxman (D-Cal) introduced the Non-Prescription Drug Modernization Act of 2007 (H.R. 4083) legislation in the House. The bill was co-sponsored by Rep. Tom Allen (D-ME) and was referred to the House Energy and Commerce Committee.

The bill will “amend the Federal Food, Drug, and Cosmetic Act to provide for the amendment or repeal of monographs, to expand the Food and Drug Administration’s (FDA) authority to regulate drug advertising.”

The Act is a reaction to a recent FDA advisory panel recommendation that the FDA should ban OTC cough and cold medications for children under the age of six. Under current law, if the FDA wants to follow its committee’s recommendations, the Agency would have to go through a lengthy rulemaking process that could take years to complete.

The Non-Prescription Drug Modernization Act would give the FDA the authority to act quickly to remove unsafe or ineffective OTC drugs, by allowing the Agency to revoke authorization to market such drugs without a lengthy rulemaking process.

The Act would allow FDA to bypass these procedures and amend or repeal a monograph in a more timely fashion in two circumstances:

1)  When FDA, on its own initiative, finds that a monograph must be amended or repealed because a drug under the monograph may pose a significant risk; or

2)  After a meeting of one of the Agency’s Advisory Committees, when FDA finds that a drug under the monograph lacks evidence of effectiveness.

The Modernization Act would also give the FDA the authority to regulate OTC drug advertisements. Currently, the FDA regulates advertisements for prescription drugs, while the Federal Trade Commission (FTC) regulates advertisements for OTC drugs. It would also provide for civil monetary penalties for direct-to-consumer OTC drug advertisement violations.

The bill would also require the FDA to report to Congress on whether any of the current OTC drug monographs are in need of review, amendment, or repeal.

(Side Note:  Join a Fantasy Congress League and you can follow the progress of this bill here.)

Posted December 11th, 2007 by Stephen Albainy-Jenei in Drug Legislation, FTC, FDA
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The US Food and Drug Administration (FDA) today announced a new program aimed at speeding up the approval process for generic drugs.

FDA predicts that the program, aptly called GIVE the Generic Initiative for Value and Efficiency, would give a gift to generic companies by helping the FDA approve generic drugs more quickly. FDA approved 682 generic drugs in fiscal year 2007, 30 pct more than it did the prior year, although an increasing number of generic applications are submitted each year.

Under the program, FDA will immediately review applications for generic drugs that face no blocking patents or exclusivity provisions. The FDA said this change will let these generic drugs reach consumers more quickly. In plain English, GIVE aims to increase the number and variety of generic drug products available to drive down the costs of drugs.

The program will focus staff efforts on program goals and provide background and impetus for development of additional review efficiencies. Additional changes anticipated include, but are not limited to:

• A continued focused hiring plan, using currently available resources, to address critical review staff needs.
• Using the Office of Pharmaceutical Science to augment review capability in microbiology (critical need area).
• Identification of supplements for low-risk manufacturing changes that may qualify for a less intense level of review.
• Base risk decisions on manufacturer’s product and process understanding and the robustness of their internal quality system to control their processes.
• Enhanced use of electronic programs for handling submissions and internal documents.
• Supplement reduction for low-risk products.
• Consideration of additional changes to application procedures to increase the availability of more lower-cost generic alternatives to the public.

FDA said it would increase its current review staff of 215, increase the use of electronic submissions, and use other resources from within FDA to review applications.

A generic drug is identical, or bioequivalent to, a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Drug companies must submit an abbreviated new drug application (ANDA) for approval to market a generic product.

The Drug Price Competition and Patent Term Restoration Act of 1984, more commonly known as the Hatch-Waxman Act, made ANDAs possible by creating a compromise wherein generic drug companies gained greater access to the market for prescription drugs, and innovator companies gained restoration of patent life of their products lost during FDA’s approval process.

Posted October 5th, 2007 by Stephen Albainy-Jenei in Generic drugs, FDA
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Ironically, within hours of President Bush signing the FDA Amendments Act of 2007 into law, a report is released finding the U.S. Food and Drug Administration doesn’t do enough to ensure the safety of patients who help test drugs in clinical trials

The New York Times quotes Daniel Levinson, the inspector general of the Department of Health and Human Services, as saying FDA officials do not know how many clinical trials are being conducted and have audited fewer than 1 percent of the testing sites.

While FDA inspectors often show up long after the tests have been completed, the agency said it lacks the resources to do the job properly — it has 200 inspectors responsible for 350,000 testing sites.

Being Washington, the report also blames the regulators noting that FDA officials downgraded negative findings from inspectors 68 percent of the time. Among the remaining cases, the agency almost never followed up with inspections to determine whether the corrective actions that the agency demanded had occurred, the report found.

The FDA disqualified researchers from conducting further clinical trials 26 times from 2000 to 2005 and disqualified their data twice, although it found serious problems at trial sites 348 times.

An inspector general’s report in 2000 criticized the oversight of clinical trials and noted that the inspections mostly focused on whether study information was accurate and not on whether human subjects were protected.

See the NY Times article here.

Posted September 28th, 2007 by Stephen Albainy-Jenei in FDA
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