Posted: 25 Jan 2015 06:55 PM PST
By Kurt R. Karst –
It’s been a little more than 2.5 years since Section 505(w) was added to the FDC Act by Section 1134 of the 2012 FDA Safety and Innovation Act (“FDASIA”). Section 505(w), titled “Deadline For Determination on Certain Petitions,” requires FDA to issue a final, substantive determination on a petition submitted pursuant to 21 C.F.R. § 314.161(b) – a so-called “discontinuation petition” – “no later than 270 days after the date the petition is submitted.” The provision, which many believe was included in FDASIA to make the bill compliant with the Statutory Pay-As-You-Go Act of 2010 (see our FDASIA Summary here), applies to any discontinuation petition submitted to FDA on or after July 9, 2012. Unlike Section 505(q) petitions, which FDA must respond to within 150 days of receipt, FDA is not required to report to Congress on the Agency’s track record in responding to discontinuation petitions. (Last December, we reported on FDA’s most recent Report to Congress on 505(q) petitions.) So we took it upon ourselves to assess – and grade – FDA on the Agency’s efforts to meet the statutory deadline. After all, when FDA is not subject to any oversight, the Agency has been known to slip on meeting statutory deadlines. Just consider FDA’s 30-plus-year track record in meeting (or not) the 90-day statutory deadline for ruling on ANDA suitability petitions. This blogger analyzed that record in an article for the William Mitchell Law Review’s Hatch-Waxman 30th anniversary edition, titled “Letting the Devil Ride: Thirty Years of ANDA Suitability Petitions Under the Hatch-Waxman Act.”
As we noted when the provision that would become FDC Act § 505(w) was initially proposed under FDC Act § 505(j)(4)(I), FDA may refuse to approve an ANDA if the Agency determines that the Reference Listed Drug (“RLD”) was withdrawn from sale for reasons of safety or effectiveness. In addition, FDA can withdraw (or suspend) approval of an ANDA if the RLD is withdrawn from sale for reasons of safety or effectiveness (FDC Act § 505(j)(6)). In that case, the RLD is removed from the Orange Book (FDC Act § 505(j)(7)(C)).
The Hatch-Waxman Amendments didn’t specify any procedure for FDA to follow in determining whether a drug that is withdrawn from sale by its manufacturer is withdrawn for safety or effectiveness reasons. So FDA took it upon itself to create such a procedure, which is laid out at 21 C.F.R. § 314.161. Prior to FDASIA’s enactment, FDA’s timeframe for responding to withdrawal petitions was all over the map; however, that’s probably because the Agency generally responded to discontinuation petitions only when it was necessary to do so (i.e., when FDA was nearing an ANDA approval decision).
By our tally, 41 discontinuation petitions were submitted to FDA since the July 2012 enactment of FDASIA and the end of 2014. (As a side note, the first such petition, from August 2012, was the topic of a lawsuit against FDA – see our previous posts hereand here.) Of those 41 petitions, 3 (7.32%) were withdrawn before an FDA decision was published, and 3 (7.32%) are pending and within the 270-day deadline. That leaves 35 petitions for which there is either a timely or untimely FDA decision. So how did the Agency do? As shown in the table below, FDA has timely responded to nearly 86% of Section 505(w) petitions. That puts FDA in solid “B” grade territory.
As you can calculate from the docket-specific information below that we compiled, most of the missed deadlines were not too far off the 270-day mark. So, if we’re grading on a curve (vis-à-vis other statutory deadlines for FDA action), then perhaps FDA’s B” grade can be bumped up to a “B+” or “A-”.
It’s been a little more than 2.5 years since Section 505(w) was added to the FDC Act by Section 1134 of the 2012 FDA Safety and Innovation Act (“FDASIA”). Section 505(w), titled “Deadline For Determination on Certain Petitions,” requires FDA to issue a final, substantive determination on a petition submitted pursuant to 21 C.F.R. § 314.161(b) – a so-called “discontinuation petition” – “no later than 270 days after the date the petition is submitted.” The provision, which many believe was included in FDASIA to make the bill compliant with the Statutory Pay-As-You-Go Act of 2010 (see our FDASIA Summary here), applies to any discontinuation petition submitted to FDA on or after July 9, 2012. Unlike Section 505(q) petitions, which FDA must respond to within 150 days of receipt, FDA is not required to report to Congress on the Agency’s track record in responding to discontinuation petitions. (Last December, we reported on FDA’s most recent Report to Congress on 505(q) petitions.) So we took it upon ourselves to assess – and grade – FDA on the Agency’s efforts to meet the statutory deadline. After all, when FDA is not subject to any oversight, the Agency has been known to slip on meeting statutory deadlines. Just consider FDA’s 30-plus-year track record in meeting (or not) the 90-day statutory deadline for ruling on ANDA suitability petitions. This blogger analyzed that record in an article for the William Mitchell Law Review’s Hatch-Waxman 30th anniversary edition, titled “Letting the Devil Ride: Thirty Years of ANDA Suitability Petitions Under the Hatch-Waxman Act.”
As we noted when the provision that would become FDC Act § 505(w) was initially proposed under FDC Act § 505(j)(4)(I), FDA may refuse to approve an ANDA if the Agency determines that the Reference Listed Drug (“RLD”) was withdrawn from sale for reasons of safety or effectiveness. In addition, FDA can withdraw (or suspend) approval of an ANDA if the RLD is withdrawn from sale for reasons of safety or effectiveness (FDC Act § 505(j)(6)). In that case, the RLD is removed from the Orange Book (FDC Act § 505(j)(7)(C)).
The Hatch-Waxman Amendments didn’t specify any procedure for FDA to follow in determining whether a drug that is withdrawn from sale by its manufacturer is withdrawn for safety or effectiveness reasons. So FDA took it upon itself to create such a procedure, which is laid out at 21 C.F.R. § 314.161. Prior to FDASIA’s enactment, FDA’s timeframe for responding to withdrawal petitions was all over the map; however, that’s probably because the Agency generally responded to discontinuation petitions only when it was necessary to do so (i.e., when FDA was nearing an ANDA approval decision).
By our tally, 41 discontinuation petitions were submitted to FDA since the July 2012 enactment of FDASIA and the end of 2014. (As a side note, the first such petition, from August 2012, was the topic of a lawsuit against FDA – see our previous posts hereand here.) Of those 41 petitions, 3 (7.32%) were withdrawn before an FDA decision was published, and 3 (7.32%) are pending and within the 270-day deadline. That leaves 35 petitions for which there is either a timely or untimely FDA decision. So how did the Agency do? As shown in the table below, FDA has timely responded to nearly 86% of Section 505(w) petitions. That puts FDA in solid “B” grade territory.
Year | Timely | Untimely | Withdrawn | Pending |
2012 | 5 | 0 | 1 | 0 |
2013 | 16 | 4 | 1 | 0 |
2014 | 9 | 1 | 1 | 3 |
TOTAL | 30 | 5 | 3 | 3 |
(85.71%) | (14.29%) | (7.32%) | (7.32%) |
Docket No. | Product | Petition Receipt Date | Petition Decision Date | Disposition | Timely? |
| FDA-2012-P-0895 | OPANA ER (oxymorphone HCI) Extended-release Tablets | Not Disc.for S/E (78 FR 38053) | YES | ||
| FDA-2012-P-0916 | DIFFERIN (adapalene) Solution 0.1% | Not Disc.for S/E (78 FR 6823) | YES | ||
| FDA-2012-P-1000 | Dapiprazole HCl Ophthalmic Solution, 0.5% | Not Disc.for S/E (78 FR 27971) | YES | ||
| FDA-2012-P-1034 | SUBOXONE (buprenorphine HCl and naloxone HCl) Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg | Not Disc.for S/E (78 FR 34108) | YES | ||
| FDA-2012-P-1104 | JUVISYNC (sitagliptin and simvastatin) Tablets, 10mg/eq to 50mg base, 20mg/eq to 50mg base, and 40mg/eq to 50mg base | Withdrawn | NA | ||
| FDA-2012-P-1071 | GEREF (sermorlin acetate) Injection, 0.5 mg Base/Vial and 1.0 mg Base/Vial; GEREF (sermorelin acetate) Injection, 0.05 mg Base/Amp | Not Disc.for S/E (78 FR 14095) | YES | ||
Docket No. | Product | Petition Receipt Date | Petition Decision Date | Disposition | Timely? |
| FDA-2013-P-0113 | CORDRAN (flurandrenolide) Ointment USP, 0.025% and 0.05% | Not Disc.for S/E (78 FR 35038) | YES | ||
| FDA-2013-P-0241 | CYTOXAN (cyclophosphamide) for Injection (lyophilized formulations), 100 mg/vial, 200 mg/vial, 500 mg/vial, 1 gram (g)/vial, and 2 g/vial; CYTOXAN (cyclophosphamide) for Injection (non-lyophilized formulations), 100 mg/vial and 200 mg/vial | Not Disc.for S/E (78 FR 47321) | YES | ||
| FDA-2013-P-0303 | METADATE ER (methylpheindate HCl) Extended-release Tablets, 10 mg | Not Disc.for S/E (78 FR 40484) | YES | ||
| FDA-2013-P-0336 | BENADRYL (diphenhydramine HCl) Injection, 50 mg /mL | Withdrawn | NA | ||
| FDA-2013-P-0503 | UROCIT-K Powder (potassium citrate), 10 mEq/packet and 20 mEq/packet | Not Disc.for S/E (78 FR 63228) | YES | ||
| FDA-2013-P-0573 | BANZEL (rufinamide) Tablets, 100 mg | Not Disc.for S/E (78 FR 69856) | YES | ||
| FDA-2013-P-0631 | MOBAN (molindone HCL) Tablets, 5 mg, 10 mg, 25 mg, 50 mg, and 100 mg | Not Disc.for S/E (78 FR 66742) | YES | ||
| FDA-2013-P-0665 | INTAL (cromolyn sodium) Inhalation Capsules, 20 mg | Not Disc.for S/E (78 FR 63227) | YES | ||
| FDA-2013-P-0671 | PARAFLEX (chlorzoxazone) Tablets, 250 mg | Not Disc.for S/E (78 FR 63228) | YES | ||
| FDA-2013-P-0768 | ZEFAZONE (cefmetazole sodium) Injection, EQ 1 g base/vial and EQ 2 g base/vial; ZEFAZONE (cefmetazole sodium) Intravenous Solution, EQ 20 mg base/mL and EQ 40 mg base/mL | Not Disc.for S/E (79 FR 13307) | YES | ||
| FDA-2013-P-0775 | INVEGA (paliperidone) Extended-release Tablets, 12 mg | Not Disc.for S/E (78 FR 66009) | YES | ||
| FDA-2013-P-0886 | JADELLA (levonorgestrel) Implant, 75 mg | Not Disc.for S/E (79 FR 51575) | NO | ||
| FDA-2013-P-0948 | STAVZOR (valproic acid) Delayed-release Capsules, 125 mg, 250 mg, and 500 mg | Not Disc.for S/E (79 FR 9225) | YES | ||
| FDA-2013-P-1055 | SUBUTEX (buprenorphine HCl) Sublingual Tablets, EQ. 2 mg and 8 mg Base | Due on or about 5/17/2014 | Pending | NO | |
| FDA-2013-P-1199 | SKELAXIN (metaxalone) Tablets, 400 mg | Not Disc.for S/E (79 19102) | YES | ||
| FDA-2013-P-1379 | PREZISTA (darunavir) Tablets, 400 mg | Not Disc.for S/E (79 FR 18558) | YES | ||
| FDA-2013-P-1510 | LUPRON DEPOT-PED (leuprolide acetate for depot suspension), 3.75 mg/vial and 7.5 mg/vial | Not Disc.for S/E (79 FR 49327) | NO | ||
| FDA-2013-P-1515 | ZOVIRAX (acyclovir sodium) for Injection, EQ 1 g base/vial | Not Disc.for S/E (79 FR 20214) | YES | ||
| FDA-2013-P-1516 | Sodium Pertechnetate Tc-99m (technetium Tc-99m sodium pertechnetate), 2 to 100 mCi/mL and 10 to 60 mCi/mL | Not Disc.for S/E (79 FR 30851) | YES | ||
| FDA-2013-P-1609 | LUPRON DEPOT (leuprolide acetate for depot suspension) Injection, 3.75 mg/vial | Not Disc.for S/E (79 FR 60852) | NO | ||
| FDA-2013-P-1654 | Leucovorin Calcium Injection-Preservative Free, 10 mg/lmL, 10 mL total fill volume | Not Disc.for S/E (79 FR 34313) | YES | ||
Docket No. | Product | Petition Receipt Date | Petition Decision Date | Disposition | Timely? |
| FDA-2014-P-0169 | THIOPLEX (thioepa) Injection, 15mg/vial | Withdrawn | NA | ||
| FDA-2014-P-0315 | FUSILEV (levoleucovorin calcium) Injection, 175 mg/17.5 mL and 250 mg/25 mL | Not Disc.for S/E (79 FR 49780) | YES | ||
| FDA-2014-P-0377 | ACTHAR GEL SYNTHETIC (seractide acetate) Injection | Due on or about 12/27/2014 | Pending | NO | |
| FDA-2014-P-0549 | SULAR (nisoldipine) Extended-release Tablets, 10 mg, 20 mg, 25.5 mg, 30 mg, and 40 mg | Not Disc.for S/E (79 FR 50569) | YES | ||
| FDA-2014-P-0637 | FUSILEV (levoleucovorin calcium) Injection, 175 mg/17.5 mL and 250 mg/25 mL | Not Disc.for S/E (79 FR 49780) | YES | ||
| FDA-2014-P-0861 | FOSAMAX (alendronate sodium) EQ 10 mg, EQ 35 mg base, and EQ 40 mg base | Not Disc.for S/E (79 FR 47648) | YES | ||
| FDA-2014-P-0979 | DIAMOX (acetazolamide) Injection, 500mg base/vial | Not Disc.for S/E (79 FR 64201) | YES | ||
| FDA-2014-P-0980 | REYATAZ (atazanavir sulfate) Capsules, 100 mg | Not Disc.for S/E (80 FR 509) | YES | ||
| FDA-2014-P-1101 | LOESTRIN 21 1/20 (ethinyl estradiol;norethindrone acetate) Tablets, 0.02 mg/1 mg | Denied (Moot) | YES | ||
| FDA-2014-P-1102 | LOESTRIN FE 1/20 (ethinyl estradiol ;norethindrone acetate) Tablets, 0.02 mg/1 mg | Denied (Moot) | YES | ||
| FDA-2014-P-1472 | NAMENDA (memantine HCl) Tablets, 5 mg & 10 mg | Due on or about 6/26/2015 | Pending | NA | |
| FDA-2014-P-1483 | NAMENDA (memantine HCl) Tablets, 5 mg & 10 mg | Due 6/28/2015 | Pending | NA | |
| FDA-2014-P-1883 | LEVATOL (penbutolol sulfate) Tablets, 10 mg and 20 mg | Not Disc.for S/E (80 FR 1423) | YES | ||
| FDA-2014-P-1896 | Oxytocin in Dextrose 5% Injection (5, 10, and 20 units) | Due on or about 8/9/2015 | Pending | NA |
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